New drug treatment could reduce body weight in obese patients with rare genetic disorder

As part of a phase II study at Charité - Universitätsmedizin Berlin and the Berlin Institute of Health, two obese patients with a rare genetic disorder were given a drug treatment to stimulate the satiety center in the brain. After only a few weeks, both patients, which were severely hyperphagic before the study start, showed a normalization of their hunger feeling as well as a significant reduction of body weight. Results from this study have been published in the current edition of the New England Journal of Medicine.

Our understanding of the factors involved in the dysregulation of normal body weight remains rudimentary. However it is known that mutations in certain genes play could lead to the development of early onset obesity due to a severe hyperphagia. MC4R is one example; it provides the blueprint for the melanocortin-4 receptor (MC4R) setmelanotide, which regulates energy balance and weight. Activation of the receptor by MSH (melanocyte-stimulating hormone) leads to a reduction in the sensation of hunger. Patients deficient in MSH show severe hyperphagia, and develop obesity within the first months of life.

The study team, led by Dr. Peter Kühnen - a physician at the Institute for Experimental Pediatric Endocrinology -- treated two patients with congenital proopiomelanocortin (POMC) deficiency. POMC is a precursor of the hormone MSH, and is secreted by the hypothalamus; deficiency causes significantly increased hunger. The researchers set out to test whether the new drug might replace the effect of the prohormone through targeted activation of the satiety center. First effects were recorded within a few weeks of the start of treatment. Patient 1, whose starting weight was 155 kg, achieved a total weight loss of 51 kg over a period of 42 weeks; patient 2 (starting weight 152.8 kg) lost a total of 20.5 kg over the course of 12 weeks.

"Our study results confirm the crucial role of the MC4R signaling pathway in appetite regulation, and represent an important contribution to our understanding of the fundamental processes involved in the control of body weight" says Dr. Peter Kühnen. He goes on to add: "It currently remains unclear, however, whether this treatment will be of benefit to patients whose obesity has no clear genetic cause. Further studies will be needed to elucidate this."

Ref : http://www.nejm.org/doi/full/10.1056/NEJMoa1512693

Inosine treatment can help restore motor control after cortical injury

Brain tissue can die as the result of stroke, traumatic brain injury, or neurodegenerative disease. When the affected area includes the motor cortex, impairment of the fine motor control of the hand can result. In a new study published in Restorative Neurology and Neuroscience, researchers found that inosine, a naturally occurring purine nucleoside that is released by cells in response to metabolic stress, can help to restore motor control after brain injury.

Based on evidence from rodent studies, researchers used eight rhesus monkeys ranging in age from 5 to 10 years (approximately equivalent to humans from 15 to 30 years of age). All received medical examinations and motor skills were tested, including video recording of fine motor functions used to retrieve small food rewards. All monkeys were given initial MRI scans to ensure there were no hidden brain abnormalities.

Brain injuries were created in the area controlling each monkey's favored hand. Four monkeys received inosine treatment, while four received a placebo. Research staff were not informed regarding which monkeys were included in the treatment vs placebo groups. Recovery of motor function was then measured for a period of 14 weeks after surgery.

While both the treated and placebo groups recovered significant function, three out of four of the treated monkeys were able to return to their pre-operative grasping methods. The placebo group developed a compensatory grasping method for retrieving food rewards unlike the original thumb-and-finger method.

"In the clinical context, the enhanced recovery of grasp pattern suggests that inosine facilitates greater recovery from this type of cortical injury and motor impairment," explained lead investigator Tara L. Moore, PhD, of the Department of Anatomy & Neurobiology and the Department of Neurology, Boston University School of Medicine, Boston, MA, USA. "To our knowledge, this is the first study to demonstrate the positive effects of inosine for promoting recovery of function following cortical injury in a non-human primate."

Inosine has also been administered in human clinical trials for multiple sclerosis and Parkinson's disease and has been proven to be safe in doses up 3000 mg/day. Athletes have used inosine as a nutritional supplement for decades, and inosine supplements are widely available commercially. "Given the effectiveness of inosine in promoting cortical plasticity, axonal sprouting, and dendritic branching, the present evidence of efficacy after cortical injury in a non-human primate, combined with a long history of safe use, indicates a need for clinical trials with inosine after cortical injury and spinal cord injury," noted Dr. Moore.

The study points to neural plasticity, whereby the brain essentially "re-wires" connections between neurons to reestablish control pathways, as a therapeutic target for the recovery of fine motor control and grasping ability. Further study of cortical tissue from these monkeys is currently being completed and may provide further insights into the mechanisms underlying recovery.

New drug could help decrease symptoms of asthma

"This new drug could be a game changer for future treatment of asthma" - Professor Chris Brightling, NIHR Senior Research Fellow at the University of Leicester.

The first new asthma pill for nearly 20 years has the power to significantly reduce the severity of the condition, a study led by the University of Leicester has found.

The research was funded by Novartis Pharmaceuticals, National Institute for Health Research (NIHR) and the EU (AirPROM), and is described by the lead researcher as "a game changer for future treatment of asthma."

Three people die every day because of asthma attacks and research shows that two thirds of asthma deaths are preventable, according to Asthma UK.

Fevipiprant (QAW039) significantly decreased the symptoms of asthma, improved lung function, reduced inflammation and repaired the lining of airways.

The drug is currently being evaluated in late stage clinical trials for efficacy in patients with severe asthma, according to ClinTrials.gov.

A total of 61 people took part in the research. One group was given 225mg of the drug twice a day for 12 weeks and the other participants were assigned to a placebo group. Fevipiprant and the placebo were added to the medications the participants were already taking.

The study was designed primarily to examine the effects on inflammation in the airway by measuring the sputum eosinophil count.

The sputum eosinophil is an inflammation measurement of a white blood cell that increases in asthma and is used to assess the severity of this condition.

People who do not have asthma have a percentage of less than one and those with moderate-to-severe asthma typically have a reading of about five per cent.

The rate in people with moderate-to-severe asthma taking the medication was reduced from an average of 5.4 percent to 1.1 percent over 12 weeks, according to the study published today in the prestigious The Lancet Respiratory Medicine journal.

Professor Christopher Brightling, who is a NIHR Senior Research Fellow and Clinical Professor in Respiratory Medicine at the University of Leicester, led the study at the NIHR Respiratory Biomedical Research Unit, which is based at the Glenfield Hospital in Leicester.

Professor Brightling said: "A unique feature of this study was how it included measurements of symptoms, lung function using breathing tests, sampling of the airway wall and CT scans of the chest to give a complete picture of how the new drug works.

"Most treatments might improve some of these features of disease, but with Fevipiprant improvements were seen with all of the types of tests.

"We already know that using treatments to target eosinophilic airway inflammation can substantially reduce asthma attacks.

"This new treatment, Fevipiprant, could likewise help to stop preventable asthma attacks, reduce hospital admissions and improve day-to-day symptoms- making it a 'game changer' for future treatment."

Gaye Stokes from Grantham in Lincolnshire has had severe asthma for 16 years. She took part in the trial and was part of the Fevipiprant group.

The 54-year-old said: "I knew straight away that I had been given the drug. I felt like a completely different person. I had more get up and go, I was less wheezy and for the first time in years I felt really, really well.

"For me, it felt like a complete wonder drug and I can't wait for it to be available because I really think it could make a huge difference to me."

After the 12 week trial and Gaye stopped receiving the drug, she said her health started to "go downhill again very quickly".

Professor Brightling added that the latest advance underpinned the work of the Leicester Precision Medicine Institute, a Centre of Excellence that coalesces and aligns the research missions of the University of Leicester and the NHS in Leicester.

Future treatment of human disease will increasingly move from a 'one size fits all' approach to one of tailoring the treatment to the individual patient.

Asthma is a long-term condition that affects the airways. When a person with asthma comes into contact with something that irritates their sensitive airways it causes the body to react in several ways which can include wheezing, coughing and can make breathing more difficult.

The NIHR Leicester Respiratory Biomedical Research Unit - a partnership between the University of Leicester and Leicester's Hospitals - focuses on promoting the development of new and effective therapies for the treatment of respiratory diseases including severe asthma and chronic obstructive pulmonary disease (COPD).

AirPROM stands for 'Airway Disease Predicting Outcomes through Patient Specific Computational Modelling'.

This is the technical name for the five year Europe-wide, EU funded project, which aimed to produce computer and physical models of the whole human airway system for people with asthma and chronic obstructive pulmonary disease (COPD).

AirPROM has demonstrated how an integrated approach, involving modelling, measurement and clinical validation, can accelerate the development of new therapies and improve existing methods.

New drug could help decrease symptoms of asthma

New Antibiotic Discovered in the Nose

German researchers analyzed germs that inhabit the human body and found that about 30 percent of people had Staphylococcus aureus bacteria in their noses, but 70 percent did not, the Associated Press reported.

Those without S. aureus have another type of bacteria -- Staphyloccus lugdunensis -- in the nose that produces an antibiotic that keeps S. aureus in check, according to the study published online in the journal Nature.

Lugdunin is an antibiotic compound, a thiazolidine-containing cyclic peptide. It was isolated in 2016 after Staphylococcus lugdunensis was identified as the species of bacteria from the human nose that suppressed growth of species of disease-causing bacteria in that part of the humanmicrobiome. 

Ludgunin is a non-ribosomally synthesized cyclic peptide that inhibits growth of Staphylococcus aureus strain. The lugdunin genes are located on a 30-kbp operon. The genes lugA, lugB, lugC, and lugD encode four non-ribosomal peptide synthases, which are preceded by a putative regulator gene lugR

The scientists isolated this antibiotic, which they call lugdunin, and found that it was effective in treating mice whose skin was infected with S. aureus, the AP reported.

Lugdunin may offer a new way to fight antibiotic-resistant staph bacteria, one of the superbugs that pose a major health threat worldwide. Tests of lugdunin in humans have yet to be conducted.

FDA Approves First Generic Version of Widely Used Influenza Drug Tamiflu

In continuation of my update on tamiflu oseltamivir phosphate

U.S. Food and Drug Administration approved the first generic version of Tamiflu (oseltamivir phosphate), a widely used medication for the treatment of the flu (influenza A and B) in patients two weeks of age and older who have had flu symptoms for no more than 48 hours; and prevention of the flu in patients one year of age and older. Tamiflu was approved in 1999.

The FDA is committed to improving patient access to safe and effective generic drugs. Generic drugs approved by the FDA have the same high-quality and strength as brand-name drugs. The generic manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs.

The most common side effects reported by people using oseltamivir phosphate in clinical trials included nausea and vomiting.

Patients must use oseltamivir phosphate as directed by their health care provider. Oseltamivir phosphate does not take the place of receiving a flu vaccination. Talk to your health care provider about when you should receive an annual flu vaccination.

Oseltamivir phosphate does not treat or prevent illness caused by infections other than the influenza virus, and oseltamivir phosphate does not prevent bacterial infections that may happen with the flu. The FDA does not know if oseltamivir phosphate is effective in people who start treatment after two days of developing symptoms, or have weakened immune systems.

Patients and health care providers may find more information on oseltamivir phosphate in the drug label.

FDA Approves Flonase Sensimist Allergy Relief

In continuation of my update on fluticasone

GSK Consumer Healthcare announced today that the U.S. Food and Drug Administration (FDA) has approved Flonase® Sensimist™ Allergy Relief (fluticasone furoate, 27.5 mcg spray) as an over-the-counter (OTC) treatment for symptoms associated with seasonal and perennial allergies. Previously available by prescription as Veramyst®, Flonase Sensimist is the latest Rx-to-OTC switch from GSK.

Flonase Sensimist helps block six allergic substances*, providing non-drowsy, 24-hour relief of both nose- and eye-related allergy symptoms like itchy, watery eyes**, nasal congestion, runny nose, itchy nose and sneezing.

“There are roughly 50 million people in the United States who suffer from allergies,2 and, as a category leader, GSK continues to innovate to satisfy the needs of all allergy sufferers,” said Amardeep Kahlon, Director of Marketing. “In the case of Flonase Sensimist, GSK is proud to offer an additional treatment option that not only provides more complete allergy symptom relief1 but also suits specific consumer preferences.”

Additional key features of Flonase Sensimist include:

• Nasal allergy relief indicated for adults and children ages 2 and older**
• Scent-free
• Alcohol-free
• Little or no drip

Flonase Sensimist will be nationally available OTC in early 2017.

About Flonase Sensimist

Flonase Sensimist (fluticasone furoate, 27.5 mcg spray) is an approved over-the-counter treatment for symptoms associated with seasonal and perennial allergic rhinitis including sneezing, runny nose, itchy nose, congestion, and itchy, watery eyes.**

FDA Approves Flonase Sensimist Allergy Relief

FDA Approves Qbrelis (lisinopril) Oral Solution for Pediatric Patients 6 Years of Age and Older

We know that,  Lisinopril is a drug of the angiotensin-converting enzyme (ACE) inhibitor class used primarily in treatment of high blood pressure, heart failure, and after heart attacks. It is also used for preventing kidney and eye complications in people with diabetes. Its indications,contraindications, and side effects are as those for all ACE inhibitors.

Lisinopril was the third ACE inhibitor (after captopril and enalapril) and was introduced into therapy in the early 1990s. A number of properties distinguish it from other ACE inhibitors: It ishydrophilic, has a long half-life and tissue penetration, and is not metabolized by the liver.

Now Silvergate Pharmaceuticals, Inc., leader in the development and commercialization of innovative and safe medicines for children, today announced that the United States Food and Drug Administration (FDA) approved Qbrelis (Lisinopril) Oral Solution, the first and only FDA-approved Lisinopril oral solution. Qbrelis is indicated for the treatment of hypertension (high blood pressure) in adult patients and pediatric patients 6 years of age and older, adjunct therapy for heart failure, and treatment of acute myocardial infarction in adults. 

“We are excited to launch our second product focused on pediatric patients and pediatric hypertension” said Frank Segrave, President & CEO, Silvergate Pharmaceuticals, Inc. “Qbrelis provides a ready-to-use oral solution for these children with the additional assurance of an FDA approved medication. As a company, we continue to focus on pediatric medications that are safe, effective, and readily available.”

Qbrelis enables weight-based dosing for children 6 years of age and older who until now have relied on an adjusted adult dose. Qbrelis will be available through an extensive network of pharmacies and a qualified mail order service. For additional information on how to obtain Qbrelis, please call 1-855-379-0382.

About Qbrelis

Qbrelis delivers the trusted efficacy of lisinopril (an ACE inhibitor), the effectiveness of which has been well established in clinical trials.1 As a unique formulation of an oral solution, Qbrelis provides consistent potency and stability in each dose1, in addition to the quality of a product made in accordance with FDA regulations and requirements. People who have trouble swallowing lisinopril tablets may also benefit from Qbrelis.

Qbrelis reduces blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Control of high blood pressure should be part of a comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake.

More info @ https://www.drugs.com/history/qbrelis.html

Lisinopril oral solution approved for treatment of hypertension in children and adults

Silvergate Pharmaceuticals, Inc.  leader in the development and commercialization of innovative and safe medicines for children, today announced that the United States Food and Drug Administration (FDA) approved Qbrelis™ (Lisinopril) Oral Solution, the first and only FDA-approved Lisinopril oral solution. Qbrelis™ is indicated for the treatment of hypertension (high blood pressure) in adult patients and pediatric patients 6 years of age and older, adjunct therapy for heart failure, and treatment of acute myocardial infarction in adults.

"We are excited to launch our second product focused on pediatric patients and pediatric hypertension" said Frank Segrave, President & CEO, Silvergate Pharmaceuticals, Inc. "Qbrelis provides a ready-to-use oral solution for these children with the additional assurance of an FDA approved medication. As a company, we continue to focus on pediatric medications that are safe, effective, and readily available."

Qbrelis enables weight-based dosing for children 6 years of age and older who until now have relied on an adjusted adult dose. Qbrelis will be available through an extensive network of pharmacies and a qualified mail order service.

Lisinopril oral solution approved for treatment of hypertension in children and adults

Silvergate Pharmaceuticals, Inc.  leader in the development and commercialization of innovative and safe medicines for children, today announced that the United States Food and Drug Administration (FDA) approved Qbrelis™ (Lisinopril) Oral Solution, the first and only FDA-approved Lisinopril oral solution. Qbrelis™ is indicated for the treatment of hypertension (high blood pressure) in adult patients and pediatric patients 6 years of age and older, adjunct therapy for heart failure, and treatment of acute myocardial infarction in adults.

"We are excited to launch our second product focused on pediatric patients and pediatric hypertension" said Frank Segrave, President & CEO, Silvergate Pharmaceuticals, Inc. "Qbrelis provides a ready-to-use oral solution for these children with the additional assurance of an FDA approved medication. As a company, we continue to focus on pediatric medications that are safe, effective, and readily available."

Qbrelis enables weight-based dosing for children 6 years of age and older who until now have relied on an adjusted adult dose. Qbrelis will be available through an extensive network of pharmacies and a qualified mail order service.

FDA Expands Indication For Type 2 Diabetes Treatment Synjardy (Empagliflozin/Metformin Hydrochloride) To Include Treatment-Naïve Adults

In continuation of my update on empagliflozin and metformin

The U.S. Food and Drug Administration has approved an expanded indication for Synjardy (empagliflozin and metformin hydrochloride) tablets to include treatment-naïve adults with type 2 diabetes (T2D). Synjardy, from Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY), is indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2D when treatment with both empagliflozin and metformin is appropriate.

empagliflozin Metformin

Synjardy is a combination of empagliflozin (Jardiance) and metformin — two medicines with complementary mechanisms of action — to help control blood glucose in adults with T2D. Empagliflozin, a sodium glucose co-transporter-2 inhibitor, removes excess glucose through the urine by blocking glucose re-absorption in the kidney. Metformin, a commonly prescribed initial treatment for T2D, lowers glucose production by the liver and its absorption in the intestine.

"Type 2 diabetes is a complex condition, which often requires that people take more than one treatment to manage their blood sugar," said Paul Fonteyne, president and CEO, Boehringer Ingelheim Pharmaceuticals, Inc. "The expanded indication for Synjardy further validates the potential of this combination therapy to help adults with type 2 diabetes who are not at goal, including those already being treated and, now, those at the beginning of their treatment journey."

The Synjardy label was updated to include results from a phase III, double-blind, randomized, active-controlled study that evaluated the efficacy and safety of empagliflozin in combination with metformin as initial therapy compared with the individual components. In the study, at 24 weeks, the combination of empagliflozin 10 mg or 25 mg with metformin 1000 mg or 2000 mg resulted in significant reductions in A1C (a measure of average blood glucose over the past two to three months) compared with the corresponding dose of either component alone.

Synjardy can cause serious side effects, including Lactic Acidosis (a buildup of lactic acid in the blood). Metformin, one of the medicines in Synjardy, can cause lactic acidosis, a rare, but serious condition that can cause death. Lactic acidosis is a medical emergency and must be treated in a hospital. Synjardy is not for the treatment of type 1 diabetes or diabetic ketoacidosis.

Sanofi Receives FDA Approval of Adlyxin (lixisenatide) for Treatment of Adults With Type 2 Diabetes

Sanofi announced today that the U.S. Food and Drug Administration (FDA) approved Adlyxin (lixisenatide), a once-daily mealtime GLP-1 receptor agonist injection indicated as an adjunct to diet and exercise for the treatment of adults with type 2 diabetes.

"The approval of Adlyxin reaffirms our continued commitment to addressing the challenges faced by people living with diabetes when trying to reach and maintain their individual blood glucose (HbA1c) targets," said Peter Guenter, Executive Vice President, Head, Global Diabetes & Cardiovascular Business Unit, Sanofi. "We are pleased with this approval, as it offers us the opportunity to continue helping patients treated with basal insulin who remain uncontrolled."

The approval of Adlyxin was based on FDA review of results from the GetGoal clinical program and findings from the ELIXA trial, which successfully addressed the FDA's request to demonstrate CV safety. The GetGoal clinical program, which included 13 clinical trials involving more than 5,000 adults with type 2 diabetes worldwide, evaluated the safety and efficacy of lixisenatide in adults with type 2 diabetes. All studies of the GetGoal program successfully met the primary efficacy endpoint of HbA1c reduction. The most common adverse events reported for Adlyxin included nausea, hypoglycemia and vomiting.

Adlyxin will be available in a disposable pre-filled pen in a single dose of 20 micrograms. Patients will also receive a disposable pre-filled pen in a single dose of 10 micrograms that they should initiate once daily for 14 days. On Day 15, patients will increase dosage to 20 micrograms once daily.

Adlyxin is approved under the proprietary name, Lyxumia® in more than 60 countries and marketed in over 40. Commercial launches include most EU countries, Japan, Brazil, Mexico and India. Adlyxin was in-licensed from Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL), www.zealandpharma.com.

About Adlyxin

Adlyxin is a once-daily glucagon-like peptide-1 receptor agonist (GLP-1 RA) for the treatment of adult patients with type 2 diabetes mellitus as an adjunct to diet and exercise. GLP-1 is a peptide hormone that is released within minutes after eating a meal. It is known to suppress glucagon secretion from pancreatic alpha cells and stimulate glucose-dependent insulin secretion by pancreatic beta cells. Adlyxin increases glucose-dependent insulin release, decreased glucagon secretion, and slows gastric emptying.

AbbVie Receives U.S. FDA Approval of Once-Daily Viekira XR (dasabuvir, ombitasvir, paritaprevir and ritonavir) for the Treatment of Genotype 1 Chronic Hepatitis C

In continuation of my update on Dasabuvir,  ombitasvir, paritaprevir and ritonavir

 AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for Viekira XR (dasabuvir, ombitasvir, paritaprevir and ritonavir) extended-release tablets. Viekira XR is a once-daily, extended-release co-formulation of the active ingredients in Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) and is for the treatment of patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection, including those with compensated cirrhosis (Child-Pugh A). Viekira XR is not for people with decompensated cirrhosis.

 dasabuvir    ombitasvir

Paritaprevir  ritonavir

Viekira XR is the first co-formulated three direct-acting antiviral (DAA) treatment for adult patients with GT1 HCV. Viekira XR is given once-daily as three oral tablets and must be taken with a meal. It is used without ribavirin (RBV) in GT1b patients and in combination with twice daily RBV in GT1a patients. The approval is supported by Phase 3 clinical trials for Viekira Pak which include data that demonstrated 100 percent sustained virologic response 12 weeks following treatment (SVR12) in GT1b patients with 12 weeks of therapy without ribavirin and 95 percent SVR12 in GT1a patients when used with ribavirin for 12 or 24 weeks of therapy.

"AbbVie's work continues to contribute to the transformation of hepatitis C care through our focus on evolving our current therapies as part of our ongoing commitment to patients," said Rob Scott, M.D., vice president, development and chief medical officer, AbbVie. "The approval of Viekira XR provides a new treatment option for genotype 1 hepatitis C patients in the U.S. with clinical trial data using the components of Viekira XR demonstrating 100 percent cure rates in genotype 1b patients."

There are six major HCV genotypes (GT1-6) and GT1 is the most prevalent form of HCV in the U.S., accounting for approximately 74 percent of all cases.1 Hepatitis C continues to be an important public health issue, with the Centers for Disease Control and Prevention (CDC) estimating that in the U.S. approximately 2.7 million people are chronically infected with HCV.2

The approval of Viekira XR is supported by data from seven Phase 3 clinical trials in more than 2,300 patients who received Viekira Pak with or without RBV for 12 or 24 weeks and two bioavailability studies comparing the formulations.

About Clinical Studies

The components of Viekira XR (administered twice daily with a meal) have been studied in seven Phase 3 clinical trials where 1076 subjects (including 181 with compensated cirrhosis) received the recommended regimen of Viekira +/? RBV for 12 weeks, or for 24 weeks in GT1a patients with compensated cirrhosis. Ninety-five to 100 percent achieved SVR12, which means the hepatitis C virus is not detectable in the blood three months after treatment ends. Cure rates varied by the subtype of hepatitis C and whether or not the person had cirrhosis. Individual results may vary.

USE

Viekira XR (dasabuvir, ombitasvir, paritaprevir, and ritonavir) extended-release tablets/Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) (Viekira) are prescription medicines used with or without ribavirin to treat adults with genotype 1 chronic (lasting a long time) hepatitis C (hep C) virus infection.

Viekira can be used in people who have compensated cirrhosis.

Viekira is not for people with advanced cirrhosis (decompensated). If people have cirrhosis, they should talk to a doctor before taking Viekira.

About Viekira XR

The components of Viekira XR* have been studied in a broad range of genotype 1 (GT1) patients with chronic hepatitis C virus (HCV) infection, ranging from treatment-naïve to difficult to treat patients, such as those with compensated (mild, Child-Pugh A) cirrhosis of the liver, HCV/HIV-1 co-infection, liver transplant recipients with normal hepatic function and mild fibrosis, and those who have failed previous treatment with pegylated interferon (pegIFN) and ribavirin (RBV).

The extended-release co-formulation of these components, Viekira XR, consists of 200 mg of dasabuvir, 8.33 mg of ombitasvir, 50 mg of paritaprevir, and 33.33 mg of ritonavir per tablet, and is dosed three tablets once daily. Viekira XR must be taken with a meal, and tablets should be swallowed whole. People should not drink alcohol within four hours of taking Viekira XR. Viekira XR is contraindicated in patients with moderate to severe hepatic impairment (Child-Pugh B and C) due to risk of potential toxicity. Viekira XR is taken for 12 weeks, except in GT1a patients with cirrhosis and all liver transplant recipients with normal hepatic function and mild fibrosis, who should take it for 24 weeks. Ribavirin should be co-administered in GT1a patients and in all patients who have received a liver transplant.

Paritaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors. Paritaprevir is used in combination with AbbVie's ombitasvir with or without dasabuvir for the treatment of hepatitis C.

*Given as a fixed-dose combination of ombitasvir 25mg (an NS5A inhibitor), paritaprevir 150mg (an NS3/4A protease inhibitor), and ritonavir 100mg (an HIV-1 protease inhibitor), dosed once daily with a meal, and dasabuvir 250mg (a non-nucleoside NS5B palm polymerase inhibitor), dosed twice daily with a meal.

Eisai Inc. and Arena Pharmaceuticals Announce FDA Approval of Belviq XR (lorcaserin HCl) Extended-Release Tablets

In continuation of my update on Lorcaserin

Eisai Inc. and Arena Pharmaceuticals, Inc.   announced   the approval by  U.S. Food and Drug Administration (FDA)  the New Drug Application (NDA) for Belviq XR (lorcaserin HCl) CIV extended-release 20 mg tablets. The new formulation of lorcaserin will offer patients a once-a-day dosing option that may help them achieve and maintain weight loss. Belviq XR is expected to be available in the fall of 2016. In connection with the approval, Arena will receive a $10 million milestone payment.

Belviq XR is proven to be slowly absorbed in the body and lasts throughout the day. Both the original 10 mg twice-daily formulation of Belviq and newly-approved 20 mg once-daily extended release formulation are approved for use with a reduced-calorie diet and increased physical activity for chronic weight management in adults who have a body mass index (BMI) of 30 kg/m2 or greater (obese), or BMI of 27 kg/m2 or greater (overweight) with at least one weight-related medical condition, such as high blood pressure, high cholesterol, or type 2 diabetes. It is not known if Belviq or Belviq XR, when taken with other prescription, over-the-counter, or herbal weight-loss products, is safe and effective. It is not known if Belviq or Belviq XR changes your risk of heart problems, stroke, or death due to heart problems or stroke.

"With approximately two-thirds of the U.S. population living with extra weight or obesity, there is a significant and growing need to address chronic weight management," said Louis J. Aronne, M.D., Director of the Comprehensive Weight Control Center at Weill Cornell Medicine, physician at NewYork-Presbyterian/Weill Cornell Medical Center and Principal Investigator of the BELVIQ clinical trials. "Having a once-daily treatment may offer an option for patients to stay on track to meet their weight loss goals."

The bioequivalence and bioavailability of once-daily Belviq XR 20 mg compared with twice-daily Belviq 10 mg was based on two Phase 1 registrational clinical trials among healthy adult subjects. The most common treatment-emergent adverse events were similar to those seen in the Phase 3 clinical trials of Belviq 10 mg twice-daily.

"We're excited to offer this once-a-day option of lorcaserin," said Andrew Satlin, M.D., Executive Vice President, Neurology Business Group, Eisai Inc. "This option may provide another choice for patients who are overweight or obese and find it difficult to lose weight through diet and exercise alone. The development of this new formulation further underscores Eisai's ongoing commitment to help address the health care needs of this underserved population."

"We are pleased that once-daily Belviq XR has been approved by the FDA and will provide patients another option for weight loss," said Amit D. Munshi, Arena's President and Chief Executive Officer. "The approval of this new formulation is another example of Arena's success in supporting our collaborators."

What are Belviq and Belviq XR?

Belviq and Belviq XR are FDA-approved prescription weight-loss medications that, when used with diet and exercise, can help some overweight (Body Mass Index [BMI] ≥27 kg/m2) adults with a weight-related medical problem, or obese (BMI ≥30 kg/m²) adults, lose weight and keep it off.

It is not known if Belviq or Belviq XR when taken with other prescription, over-the-counter, or herbal weight-loss products is safe and effective. It is not known if Belviq or Belviq XR changes your risk of heart problems, stroke, or death due to heart problems or stroke.

New wonder compound offers strong protection against harmful effects of UVA rays

A new wonder compound developed by University of Bath scientists in collaboration with King's College London offers unprecedented protection against the harmful effects of UVA radiation in sunlight, which include photo-ageing, cell damage and cancer.

Most sunscreens on the market protect well against solar UVB radiation but have limited effectiveness against UVA-induced damage, relying on the reflective properties of creams to defend against dangerous UVA rays.

However this compound, called the 'mitoiron claw' by the team, offers strong protection within our cells precisely where the greatest damage from UVA occurs, and doesn't interfere with rest of the cell.

The researchers from the University of Bath, working with colleagues at Kings College London, hope to see the mitoiron claw compound added to sunscreens and skin care products within 3-4 years.

Free iron concentration is particularly high within mitochondria, the batteries of the cell, where it is needed for several vital functions. However upon exposure to UVA in sunlight, excess free iron acts as a catalyst for the production of toxic reactive oxygen species (ROS), damaging cell components such as DNA, fat and proteins thereby increasing the risk of cell death and cancer.

However this custom-designed iron chelator (a molecule that binds to an iron atom like a claw) moves directly to mitochondria where it safely binds the excess free iron, preventing it from reacting upon exposure to UVA rays.

Tests with human skin fibroblast cells exposed to UVA radiation equivalent to 140 min of uninterrupted sun exposure at sea level, showed cells treated with the mitoiron claw were completely protected against cell death. Untreated cells suffered significant cell death.

The research is published in the Journal of Investigative Dermatology.

Dr Charareh Pourzand, from the Department of Pharmacy and Pharmacology at the University of Bath, said: "The role of iron-mediated damage induced upon exposure of skin cells to UVA has been underestimated for many years. For efficient protection against UVA-induced iron damage of skin strong chelators are needed, but until now these risked toxic effects caused by non-targeted iron starvation of cells.

"Our mitochondria-targeted compound provides a solution to this problem and can address an unmet need in the skincare and sunscreen fields. This mitoiron claw is a highly effective compound, offering unprecedented protection against UVA-induced mitochondrial damage."

Now that the protective effects of the compound have been demonstrated the team, Dr Charareh Pourzand and Dr Olivier Reelfs from University of Bath and Prof Robert Hider and Dr Vincenzo Abbate at Kings College London, plans further work to explore the potential of this new type of compound.

This includes the possibility of developing therapies for diseases involving mitochondrial iron overload, such as Friedreich's ataxia.


Ref:

1. http://www.bath.ac.uk/news/2016/07/20/sun-cream-uva/

2. http://www.jidonline.org/article/S0022-202X(16)31053-3/fulltext

New wonder compound offers strong protection against harmful effects of UVA rays

Combinations of three antibiotics could help combat drug-resistant bacterial infections

Each year, approximately 700,000 people die from drug-resistant bacterial infections. A study by UCLA life scientists could be a major step toward combating drug-resistant infections.

The research, reported in the journal Royal Society Interface, found that combinations of three different antibiotics can often overcome bacteria's resistance to antibiotics, even when none of the three antibiotics on their own -- or even two of the three together -- is effective.

The researchers grew E. coli bacteria in a laboratory and treated the samples with combinations of one, two and three antibiotics from a group of 14 drugs. The biologists studied how effectively every single possible combination of drugs worked to kill the bacteria.

Some combinations killed 100 percent of the bacteria, including 94 of the 364 three-drug groupings the researchers tested. According to said Pamela Yeh, the paper's senior author and a UCLA assistant professor of ecology and evolutionary biology, the success rate might have been even greater if the researchers tested higher doses of the drugs.

Elif Tekin, the paper's lead author and a UCLA graduate student, helped create a sophisticated framework that enabled the scientists to determine when adding a third antibiotic was producing new effects that combinations of just two drugs couldn't achieve.

"Three antibiotics can change the dynamic," she said. "Not many scientists realize that three-drug combinations can have really beneficial effects that they would not have predicted even by studying all pairs of the antibiotics together."

Different classes of antibiotics use different mechanisms to fight bacteria. One class, which includes amoxicillin, kill bacteria by preventing them from making cell walls. Another disrupts their tightly coiled DNA. A third inhibits their ability to make proteins. But there had been little previous research indicating that combinations of three antibiotics might be more potent together than any two of them.

"People tend to think that you don't need to understand interactions beyond pairs," said Van Savage, a co-author of the paper and a UCLA associate professor of ecology and evolutionary biology and of biomathematics. "We found that isn't always so."

The researchers combined techniques from biology and mathematics to determine which groups of antibiotics would be most effective.

"The three antibiotics must be chosen systematically and rationally," Yeh said.

In addition to identifying certain combinations that were more potent than the researchers expected, the analysis revealed that adding a third antibiotic sometimes made the drug combination less potent -- sometimes much less so, she said.

Yeh said the findings could be one weapon to fight what has become a major public health risk, but overcoming drug resistance will require a full arsenal.

"We need sound policy to stop the overuse of antibiotics, doctors to prescribe antibiotics wisely, agriculture to stop overusing antibiotics and researchers to develop new antibiotics," she said. "We need to attack this problem from all sides. We think our contribution will buy time for researchers to better leverage existing drugs and for policymakers to develop better policy about the use of antibiotics."

Another benefit of three-drug combinations is that they could allow doctors to prescribe lower doses of each antibiotic, which could reduce side effects.

The researchers plan to make available open-access software that would let other scientists and clinicians decide which combinations of antibiotics will be most effective.

Yeh said the team's approach could also be used to study how four or more pharmaceuticals interact, and a similar mathematical framework could be used to better understand climate change (for example, to understand how temperature, rainfall, humidity and acidity of the oceans interact) and other scientific questions that have three or more key factors.

Ref : http://rsif.royalsocietypublishing.org/content/13/119/20160332