Is Green Tea a Fad or a Real Health Boost?

In continuation of my updates on Green tea

Green tea is a popular health trend, with many people sipping in hopes of deriving benefits from the brew.

There's nothing wrong with that, dietitians say -- green tea is a healthy drink loaded with antioxidants. But the jury's still out on many of its purported health benefits.

"Clinical trials related to green tea are still in their early stages," said Nancy Farrell Allen, a registered dietitian nutritionist in Fredericksburg, Va. "I say drink it, enjoy it. It's not going to hurt, and it might have worthy benefits to it. But nutrition is a science, and it takes time for our understanding to evolve."

Green tea's potential health benefits derive from catechins, which are powerful antioxidant compounds known as flavonoids, said Chelsey Schneider, clinical nutrition supervisor at Mount Sinai Beth Israel Cancer Center in New York City.

One catechin in particular, known as EGCG, is found at higher levels in green tea than in either white or black tea, she said.

"This compound can be even stronger than vitamin C and E, which are very, very strong antioxidants," Schneider said. Antioxidants help prevent damage to cells.

Green, black and white tea all come from the same plant, said Allen, who is a spokeswoman for the Academy of Dietetics and Nutrition.

Green tea is made from the leaves of the mature plant, while white tea is made of leaves plucked early in development. Black tea is made from green tea leaves that are laid out and covered with a damp cloth, she said.

"They dry and blacken and ferment a little, giving black tea that darker, richer flavor," Allen said. But this process also reduces levels of catechins in black tea.

Weight loss has been associated with green tea, with experts suggesting that its mixture of caffeine and catechins can enhance a person's metabolism and processing of fat, according to the University of California-Davis Department of Nutrition.

But it appears that folks have to drink a lot of green tea to get substantial weight loss benefits and carefully watch the rest of their diet, UC-Davis says.

Green tea also has been tied to heart health.

For example, green tea was shown to reduce "bad" LDL cholesterol in a 2018 study of more than 80,000 Chinese published in the Journal of the American Heart Association.

Evidence suggests catechins in green tea also could lower risk of heart attacks, help blood vessels relax and reduce inflammation, UC-Davis says.

Green tea even has been associated with a lower risk of some cancers.

The American Cancer Society says studies have linked green tea to a reduction in ovarian cancer risk. And UC-Davis said experimental models have shown that green tea might reduce risk of a variety of other cancers.

But a 2016 evidence review by the Cochrane Library concluded that there is "insufficient and conflicting evidence to give any firm recommendations regarding green tea consumption for cancer prevention."

Schneider said the research is limited. "Some small studies say green tea can maybe be preventative for certain cancers, like breast, ovarian, endometrial, pancreatic and oral cancers, but there aren't so many conclusive human trials that support that," she said.

Green tea also might help keep your brain younger. A 2014 study in the journal PLOS One found that Japanese who drank more green tea had significantly less decline in brain function, although researchers couldn't rule out the possibility that these folks might have other healthy habits that helped keep them mentally sharp.

One caveat with all of this research is that it tends to take place in Asian countries, where people drink much more green tea. There might be significant differences for Americans.

And the way you take your green tea could diminish any potential positive effects, Schneider added.

"A lot of people are adding processed white sugar to their green tea, which really makes something beautiful and healthy into something unhealthy," she said.

Adding milk or cream to your tea also might not be a good idea.

"There are some studies that say having milk in green tea can actually block the effects of you absorbing the antioxidant," Schneider said. "If it was me, I'd drink it straight up."

Coffee Might Be Your Go-to Brew for Weight Loss

In continuation of my update on coffee

Could America's favorite morning drink also help fight one of its biggest health issues, obesity?

That's the suggestion from a British study that finds coffee stimulates the human body's "brown fat," a heat-generating form of fat that literally burns calories in a process called thermogenesis.

"This is the first study in humans to show that something like a cup ofcoffeecan have a direct effect on our brown fat functions," said study leader Michael Symonds, of the University of Nottingham.

"The potential implications of our results are pretty big, as obesity is a major health concern for society and we also have a growing diabetes epidemic and brown fat could potentially be part of the solution in tackling them," he said in a university news release.

But one U.S. obesity and nutrition expert said it's just too early to label coffee a dieter's best friend.

"Usually thermogenic properties are too minimal and insignificant" to help someone go from overweight to normal weight, explained registered dietitian Sharon Zarabi. She directs the bariatrics program at Lenox Hill Hospital in New York City.

As Symonds' team explained, thermogenic brown fat was long thought to only exist in either human babies or hibernating animals, such as bears.

But in recent years it's been discovered in adult people. It's distinct from white fat cells, which is where the body stores excess calories.

"Brown fat works in a different way to other fat in your body and produces heat by burning sugar and fat, often in response to cold," Symonds explained. So, "increasing its activity improves blood sugar control as well as improving blood lipid [cholesterol] levels, and the extra calories burnt help with weight loss."

But can brown fat be stimulated into calorie-burning activity by something you eat or drink?

To find out, the British team used stem cell-based studies to first see if caffeine might do the trick. It did, at a certain dose.

The next step was to use high-tech imaging to track changes in brown fat stored in people's necks.

"We were able to image someone straight after they had a drink [of coffee] to see if the brown fat got hotter," said Symonds.

"The results were positive," he said, so the next step is to figure out which component of coffee -- perhaps the caffeine -- is activating brown fat.

His team is also "looking atcaffeinesupplements to test whether the effect is similar," Symonds said. "Once we have confirmed which component is responsible for this, it could potentially be used as part of a weight management regime or as part of [a] glucose regulation program to help prevent diabetes."

But Zarabi said dieters shouldn't view coffee as any magic potion for weight loss.

"I'd still recommend a cup o' joe at some point in the morning for a mental boost and pep in the day, but definitely not to help you lose weight -- unless you're using that caffeine for stimulation of a heart-pounding workout," she said.

That's because exercise remains the best and most efficient way to burn calories, Zarabi said.

But if you do choose to try coffee to lose weight, drink it black, she advised.

"This shouldn't give anyone the pass to drink unlimited amounts of coffee," Zarabi said. "And many drink coffee 'light and sweet,' which defeats the whole purpose of burning energy, because you're taking it all back in with the condiments."

AbbVie Announces US FDA Approval of Venclexta (venetoclax) as a Chemotherapy-Free Combination Regimen for Previously Untreated Chronic Lymphocytic Leukemia Patients

In continuation of my update on Venclexta (venetoclax)

AbbVie a research-based global biopharmaceutical  company,  announced that the U.S. Food and Drug Administration (FDA) has approved Venclexta (venetoclax) in combination with obinutuzumab (Gazyva®) for previously untreated patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The FDA granted Breakthrough Therapy designation for this combination therapy, and early submission of the data was provided under the Real-Time Oncology Review (RTOR) pilot program, which led to approval in just over two months, following submission of the complete application.

"This FDA approval provides a new chemotherapy-free combination treatment option for patients, and underscores the growing utility of Venclexta in CLL," said Michael Severino, M.D., vice chairman and president, AbbVie.  "The approval is based on findings from the CLL14 trial in which patients received a 12-month treatment regimen. The majority of patients receiving Venclexta in the trial remained progression-free at two years."

Data from the CLL14 trial is expected to be presented at an upcoming medical meeting and published in a journal this year.

"Patients never treated for their CLL have had to rely largely on chemotherapy as their initial treatment," said Michael Hallek, M.D., lead investigator of the CLL14 study, Department of Internal Medicine and Center of Integrated Oncology at the University Hospital Cologne in Germany, and Head of the German CLL Study Group. "The approval of the Venclexta combination means that patients with previously untreated CLL now have a finite duration, chemotherapy-free treatment option that can allow them to live longer without disease progression, induce high rates of minimal residual disease (MRD) negativity and, importantly, allow them to complete their course of therapy within 12 months. This is a major step forward in how previously untreated CLL is managed and further supports the growing benefits offered by Venclexta in CLL."

The CLL14 trial demonstrated superior progression-free survival as assessed by an independent review committee (PFS; the time from initiation of treatment until disease progression or death) in patients treated with Venclexta plus obinutuzumab compared to patients who received chlorambucil plus obinutuzumab, a commonly used standard of care. With a median follow-up of 28 months (range: 0.1 to 36 months), Venclexta plus obinutuzumab reduced the risk of progression or death by 67% compared with chlorambucil plus obinutuzumab (hazard ratio: 0.33, 95% confidence interval [CI]: 0.22, 0.51; p<0.0001).1 Median PFS was not reached in either treatment arm.1  Minimal residual disease (MRD) negativity (undetectable disease in the blood or bone marrow) was assessed as a secondary endpoint and occurs when less than one CLL cell per 10,000 leukocytes can be detected using sensitive analytical methods.  Higher rates of MRD negativity were observed with Venclexta plus obinutuzumab compared to obinutuzumab plus chlorambucil in both bone marrow (57% versus 17%, p<0.0001) and peripheral blood (76% versus 35%, p<0.0001) three months after treatment completion .

In the CLL14 trial, adverse events (AEs) were consistent with the known safety profiles of Venclexta and obinutuzumab alone. Serious adverse reactions (ARs) were reported in 49% of patients in the Venclexta plus obinutuzumab arm, most often due to febrile neutropenia and pneumonia (5% each). The most common ARs (≥15%) of any grade were neutropenia (60%), diarrhea (28%), fatigue (21%), nausea (19%), anemia (17%), and upper respiratory tract infection (17%).

Venclexta, an oral B-cell lymphoma-2 (BCL-2) inhibitor, has been granted five Breakthrough Therapy designations from the FDA.

https://en.wikipedia.org/wiki/Venetoclax

FDA Approves Victoza (liraglutide) for the Treatment of Pediatric Patients 10 Years or Older with Type 2 Diabetes

In continuation of my update on Victoza (liraglutide)

The U.S. Food and Drug Administration   approved Victoza (liraglutide) injection for treatment of pediatric patients 10 years or older with type 2 diabetes. Victoza is the first non-insulin drug approved to treat type 2 diabetes in pediatric patients since metformin was approved for pediatric use in 2000. Victoza has been approved to treat adult patients with type 2 diabetes since 2010.

“The FDA encourages drugs to be made available to the widest number of patients possible when there is evidence of safety and efficacy,” said Lisa Yanoff, M.D, acting director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “Victoza has now been shown to improve blood sugar control in pediatric patients with type 2 diabetes. The expanded indication provides an additional treatment option at a time when an increasing number of children are being diagnosed with this disease.”

Type 2 diabetes is the most common form of diabetes, occurring when the pancreas cannot make enough insulin to keep blood sugar at normal levels. Although type 2 diabetes primarily occurs in patients over the age of 45, the prevalence rate among younger patients has been rising dramatically over the past couple of decades. The Diabetes Report Card published by the U.S. Centers for Disease Control and Prevention estimates that more than 5,000 new cases of type 2 diabetes are diagnosed each year among U.S. youth younger than age 20.

Victoza improves blood sugar levels by creating the same effects in the body as the glucagon-like peptide (GLP-1) receptor protein in the pancreas. GLP-1 is often found in insufficient levels in type 2 diabetes patients. Like GLP-1, Victoza slows digestion, prevents the liver from making too much glucose (a simple sugar), and helps the pancreas produce more insulin when needed. As noted on the label, Victoza is not a substitute for insulin and is not indicated for patients with type 1 diabetes or those with diabetic ketoacidosis, a condition associated with diabetes where the body breaks down fat too quickly because there is inadequate insulin or none at all. Victoza is also indicated to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease; however, its effect on major adverse cardiovascular events in pediatrics was not studied and it is not indicated for this use in children.

The efficacy and safety of Victoza for reducing blood sugar in patients with type 2 diabetes was studied in several placebo-controlled trials in adults and one placebo-controlled trial with 134 pediatric patients 10 years and older for more than 26 weeks. Approximately 64% of patients in the pediatric study had a reduction in their hemoglobin A1c (HbA1c) below 7% while on Victoza, compared to only 37% who achieved these results with the placebo. HbA1c is a blood test that is routinely performed to evaluate how well a patient’s diabetes is controlled, and a lower number indicates better control of the disease. These results occurred regardless of whether the patient also took insulin at the same time. Adult patients who took Victoza with insulin or other drugs that increase the amount of insulin the body makes (e.g., sulfonylurea) may have an increased risk of hypoglycemia (low blood sugar). Meanwhile, pediatric patients 10 years and older taking Victoza had a higher risk of hypoglycemia regardless of whether they took other therapies for diabetes.

The prescribing information for Victoza includes a Boxed Warning to advise health care professionals and patients about the increased risk of thyroid C-cell tumors. For this reason, patients who have had, or have family members who have ever had medullary thyroid carcinoma (MTC) should not use Victoza, nor should patients who have an endocrine system condition called multiple endocrine neoplasia syndrome type 2 (MEN 2). In addition, people who have a prior serious hypersensitivity reaction to Victoza or any of the product components should not use Victoza. Victoza also carries warnings about pancreatitis, Victoza pen sharing, hypoglycemia when used in conjunction with certain other drugs known to cause hypoglycemia including insulin and sulfonylurea, renal impairment or kidney failure, hypersensitivity and acute gallbladder disease. The most common side effects are nausea, diarrhea, vomiting, decreased appetite, indigestion and constipation.

https://en.wikipedia.org/wiki/Liraglutide

FDA Approves Symdeko (tezacaftor/ivacaftor and ivacaftor) to Treat the Underlying Cause of CF in Children Ages 6-11 Years with Certain Mutations in the CFTR Gene

In continuation of my update on tezacafto

   Tezacaftor 

                                            

                                                                                             Lumacaftor/ivacaftor

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX)  announced the U.S. Food and Drug Administration (FDA) approved Symdeko (tezacaftor/ivacaftor and ivacaftor) for use in children with cystic fibrosis ages 6 through 11 years who have two copies of the F508del-CFTR mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to Symdeko. It was previously approved by the FDA for use in patients with cystic fibrosis 12 years and older with two copies of the F508del mutation or one copy of a responsive mutation in the U.S. An additional dosage strength of Symdeko tablets is now available (tezacaftor 50 mg/ivacaftor 75 mg and ivacaftor 75 mg) in connection with this approval.

“Today’s expanded approval of Symdeko in children ages 6 through 11 is an important step in our efforts to continue to bring treatment options to the youngest patients possible and importantly brings us closer to our goal of developing medicines for all people living with CF,” said Reshma Kewalramani, M.D., Executive Vice President and Chief Medical Officer at Vertex.

Vertex completed a 24-week Phase 3 open-label, multicenter study to evaluate the pharmacokinetics, safety, and tolerability of tezacaftor/ivacaftor and ivacaftor in children ages 6 through 11 years in the U.S. and Canada. The regimen was generally well tolerated, and safety data were similar to what was observed in previous studies of patients aged 12 years and older. The full data from this study will be published later this year.

“We’ve seen the clinical impact of Symdeko in people with CF aged 12 years and above, and this approval marks a crucial milestone for patients ages 6 through 11 years who may benefit from CFTR modulation, enabling us to treat the basic defect in CF at an earlier stage of disease,” said Seth Walker, M.D., University Hospitals of Cleveland, Cleveland Medical Center, Rainbow Babies and Children’s Hospital. “Symdeko is an important treatment option for eligible people with CF who either never started or have discontinued another CFTR modulator.”

About Cystic Fibrosis

Cystic Fibrosis (CF) is a rare, life-shortening genetic disease affecting approximately 75,000 people in North America, Europe and Australia.

CF is caused by a defective or missing cystic fibrosis transmembrane conductance regulator (CFTR) protein resulting from mutations in the CFTR gene. Children must inherit two defective CFTR genes — one from each parent — to have CF. There are approximately 2,000 known mutations in the CFTR gene. Some of these mutations, which can be determined by a genetic test, or genotyping test, lead to CF by creating non-working or too few CFTR proteins at the cell surface. The defective function or absence of CFTR protein results in poor flow of salt and water into and out of the cell in a number of organs. In the lungs, this leads to the buildup of abnormally thick, sticky mucus that can cause chronic lung infections and progressive lung damage in many patients that eventually leads to death. The median age of death is in the mid-to-late 20s.

About Symdeko (tezacaftor/ivacaftor and ivacaftor) 

Some mutations result in CFTR protein that is not processed or folded normally within the cell, and that generally does not reach the cell surface. Symdeko is a combination of tezacaftor and ivacaftor. Tezacaftor is designed to address the trafficking and processing defect of the CFTR protein to enable it to reach the cell surface where ivacaftor can increase the amount of time the protein stays open.

U.S. INDICATION FOR SYMDEKO® (tezacaftor/ivacaftor and ivacaftor) tablets 

Symdeko is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who have two copies of the F508del mutation, or who have at least one mutation in the CF gene that is responsive to treatment with Symdeko. Patients should talk to their doctor to learn if they have an indicated CF gene mutation. It is not known if Symdeko is safe and effective in children under 6 years of age.

https://en.wikipedia.org/wiki/Tezacaftor

https://en.wikipedia.org/wiki/Lumacaftor/ivacaftor

FDA Approves Gattex (teduglutide) for Children 1 Year of Age and Older With Short Bowel Syndrome (SBS)

In continuation of my update on Teduglutide

Takeda Pharmaceuticals, U.S.A., Inc. (“Takeda”), announced  that the U.S. Food and Drug Administration (FDA) approved extending the indication of Gattex(teduglutide) for injection to pediatric patients 1 year of age and older with Short Bowel Syndrome (SBS) who need additional nutrition or fluids from intravenous (IV) feeding (parenteral support).

In children, SBS is a life-threatening, chronic, and rare malabsorption disorder resulting from surgical removal of a large portion of the intestine, which is typically due to congenital or acquired conditions of the newborn or trauma.2-4 Children with SBS are unable to absorb enough nutrients and fluids from what they eat and drink alone.2 A goal of SBS treatment is to restore the remaining intestine’s ability to absorb nutrients and reduce long-term dependence on parenteral support (PS).

“As a pediatric gastroenterologist, one of my main treatment goals for children with SBS is to reduce their dependency on parenteral support,” said Beth Carter, MD, Medical Director of Intestinal Rehabilitation and Nutrition Support, Children’s Hospital Los Angeles. “I’m pleased that patients have access to a medication that may help them reach that goal.”

Gattex is the first and only medicine that mimics naturally occurring glucagon-like peptide-2 (GLP-2), which helps the remaining intestine absorb more nutrients.1 In a pharmacodynamic study in adults, Gattex was shown to improve the amount of fluids absorbed by the intestines.

“Addressing high unmet needs of patients with complex and debilitating gastrointestinal (GI) conditions is a focus of Takeda’s work,” said Andrew Grimm, Global Clinical Development Lead, Takeda. “As the first U.S.-approved therapy in pediatric SBS patients dependent on PS that improves absorption, Gattex offers these patients new hope to reduce PS requirements and the potential for PS independence. This approval underscores Takeda’s commitment to patients with rare and devastating GI conditions like SBS.”

In a 24-week pediatric study, Gattex helped reduce the volume of daily PS required and time spent administering PS. Some children even achieved complete freedom from PS.1 Fifty- nine pediatric patients with SBS aged 1 year through 17 years chose whether to receive Gattex or standard of care (SOC). Patients who chose to receive Gattex treatment were subsequently randomized in a double-blind manner to 0.025 mg/kg/day (n=24) or 0.05 mg/kg/day (n=26), while 9 patients enrolled in the SOC arm. The recommended dosage of Gattex is 0.05 mg/kg/day. Randomization to the Gattex dose groups was stratified by age.

At the end of the 24-week study, 69% of patients (18/26) who took Gattex 0.05 mg/kg each day reduced PS volume by 20% or more. Based on patient-diary data, patients who received Gattex 0.05 mg/kg/day experienced a 42% mean reduction in PS volume (mL/kg/day) from baseline (-23 mL/kg/day from baseline). At week 24, 38% of patients (10/26) were able to reduce PS infusion by at least 1 day per week. Patients reduced their PS infusion time by 3 hours per day on average compared to baseline. In addition, during this study 3 out of 26 (12%) children who received Gattex 0.05 mg/kg/day completely weaned off PS.

Gattex has a demonstrated safety profile that is similar overall in pediatric and adult patients. The most common adverse reactions (≥10%) seen in adult patients treated with Gattex in clinical trials were abdominal pain, nausea, upper respiratory tract infection, abdominal distension, injection site reaction, vomiting, fluid overload, and hypersensitivity

https://en.wikipedia.org/wiki/Teduglutide

FDA Approves Fragmin (dalteparin sodium) as First Anticoagulant for Venous Thromboembolism in Pediatric Patients

    

In continuation of my update on Dalteparin

U.S. Food and Drug Administration,  approved Fragmin (dalteparin sodium) injection, for subcutaneous use, to reduce the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients one month of age and older. VTE can include deep vein thrombosis (blood clot in the deep veins of the leg) and pulmonary embolism (blood clot in the lungs), which can lead to death.

“Most children who have VTE are fighting a serious underlying primary illness such as cancer or congenital heart disease. Not only are they fighting a serious illness, having a condition like VTE can then lead to significant complications and even death,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Prior to this approval, there had been no FDA-approved therapies to treat VTE in pediatric patients. Given the unmet need, we granted the Fragmin application priority review and today we are approving it as the first anticoagulant (blood thinner) indicated for pediatric patients. We remain committed to advancing treatments for children with unmet medical needs.”

VTE usually develops as a secondary complication of underlying clinical conditions such as a venous catheter, cancer, infection, congenital heart disease, and trauma or surgery. Pediatric VTE is associated with an increased risk of in-hospital mortality, recurrent VTE and post-thrombotic syndrome (damage to vein).

Fragmin was initially approved by the FDA in 1994 for adults and is a type of heparin, which works as an anticoagulant. The efficacy of Fragmin in children was based on a single trial with 38 pediatric patientswith symptomatic deep vein thrombosis and/or pulmonary embolism. Patients were treated with Fragmin for up to three months, with starting doses by age and weight. At study completion, 21 patients achieved resolution of the qualifying VTE, seven patients showed regression, two patients showed no change, no patients experienced progression of the VTE and one patient experienced recurrence of VTE.

Common side effects of patients taking Fragmin are bleeding, including hemorrhage (heavy discharge of blood from a blood vessel), thrombocytopenia (low blood platelet count), hematoma (collection of blood) or pain at the injection site and transient elevation of transaminases (elevated level of liver enzymes).

Health care professionals are advised to use caution in conditions with increased risk of hemorrhage and monitor thrombocytopenia of any degree closely. Health care professionals are warned not to use benzyl alcohol preservative multiple-dose formulations in infants as they contain benzyl alcohol and should not be used. Patients are advised to have blood count laboratory tests periodically. Health care professionals are advised to monitor patients closely for bleeding when administering Fragmin to patients who currently take anticoagulants. Patients at risk for VTE may receive certain treatments or interventions to help reduce the likelihood of the formation of blood clots (known as thromboprophylaxis), including taking anticoagulants.

The label for Fragmin contains a boxed warning to alert health care professionals and patients that epidural or spinal hematomas (accumulation of blood that can mechanically compress the spinal cord) may occur in patients who are anticoagulated due to taking certain medications called low molecular weight heparins (LMWH) or heparinoids and are receiving neuraxial anesthesia (injection near the spine) or undergoing spinal puncture (removing spinal fluid for testing). These hematomas may result in long-term or permanent paralysis. Health care professionals are advised to consider these risks when scheduling patients for spinal procedures as patients may be at a higher risk of developing VTE. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include: use of indwelling epidural catheters, use of other drugs that affect hemostasis at the same time when using Fragmin, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors and other anticoagulants; history of traumatic or repeated epidural or spinal punctures; and a history of spinal deformity or surgery. The optimal timing between the administration of Fragmin and neuraxial procedures is not known. Health care professionals are advised to monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary. Health care professionals are advised to consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis.

https://en.wikipedia.org/wiki/Dalteparin_sodium

https://www.drugbank.ca/drugs/DB06779

FDA Approves Revlimid (lenalidomide) In Combination with Rituximab for the Treatment of Adult Patients with Previously Treated Follicular Lymphoma or Marginal Zone Lymphoma

In continuation of my update on lenalidomide

Celgene Corporation,  announced the U.S. Food and Drug Administration (FDA) approved Revlimid (lenalidomide) in combination with a rituximab product (R²) for the treatment of adult patients with previously treated follicular lymphoma (FL) or marginal zone lymphoma (MZL) following Priority Review designation. This is the first FDA-approved combination treatment regimen for patients with these indolent forms of non-Hodgkin’s lymphoma (NHL) that does not include chemotherapy.

“Nearly 15 years following the initial FDA approval, Revlimid continues to demonstrate benefits for new patient populations,” said Jay Backstrom, M.D., M.P.H., Chief Medical Officer for Celgene. “Revlimid in combination with rituximab (R2) leads to immune-mediated treatment effects and represents a chemotherapy-free treatment option that can help patients with previously treated follicular lymphoma and marginal zone lymphoma delay disease progression.”

Immune dysfunction (meaning the immune system is not functioning optimally) is a defining aspect of indolent forms of NHL, including FL and MZL.1,2 When this dysfunction occurs, lymphocytes in the immune system either fail to detect or target cancerous cells.1,2

“Chemotherapy continues to be a standard of care for indolent forms of NHL, but most patients will relapse or become refractory to their current treatment,” said Meghan Gutierrez, Chief Executive Officer for the Lymphoma Research Foundation. “This approval represents a new therapeutic option for previously treated patients with follicular and marginal zone lymphomas, including those who relapse or no longer respond to initial treatment. We commend the patients and scientists who participated in the clinical study for advancing lymphoma research and treatment.”

The approval of R2 is based primarily on results from the randomized, double-blind, Phase 3 AUGMENT study, which evaluated the efficacy and safety of the R² combination versus rituximab plus placebo in patients with previously treated FL (n=295) and MZL (n=63).

In the AUGMENT study, treatment with R2 demonstrated a statistically significant improvement in the primary endpoint of progression-free survival (PFS), evaluated by an independent review committee, versus rituximab-placebo. The median PFS was 39.4 months for patients treated with R2 and 14.1 months for those treated with rituximab-placebo (HR: 0.46; 95% CI, 0.34-0.62; P<0.0001). Median follow-up time was 28.3 months (range, 0.1-51.3) in the intent to treat population (n=358). Although not statistically powered to detect a difference in overall survival, a numeric trend for improvement in overall survival (a secondary endpoint) was also seen with R2 versus rituximab-placebo (16 vs. 26 deaths) (HR: 0.61; 95% CI, 0.33-1.13).

Revlimid is only available through a restricted distribution program called Revlimid REMS® program. Revlimid has a boxed warning for embryo-fetal toxicity, hematologic toxicity, and venous and arterial thromboembolism. Adverse reactions reported in ≥15% of patients with FL/MZL treated with R2 were: neutropenia (58%), diarrhea (31%), constipation (26%), cough (24%), fatigue (22%), rash (22%), pyrexia (21%), leukopenia (20%), pruritus (20%), upper respiratory tract infections (18%), abdominal pain (18%), anemia (16%), headache (15%), thrombocytopenia (15%).

A Marketing Authorization Application for R2 is currently under review by the European Medicines Agency for the treatment of relapsed/refractory FL and MZL. A supplemental new drug application was also submitted to the Japanese Pharmaceuticals and Medical Devices Agency for an additional indication as well as dosage and administration updates for lenalidomide in combination with rituximab for the treatment of relapsed/refractory indolent B-cell NHL.

FDA Approves Sorilux for Adolescent Plaque Psoriasis

In continuation of my update on Sorilux(calcipotriene) 

 

Mayne Pharma Group Limited, announced that the US Food and Drug Administration (FDA) has approved Sorilux(calcipotriene) Foam, 0.005% in adolescents.

Sorilux is now approved for treating plaque psoriasis of the scalp and body in patients aged 12 years and older.

The FDA approved Sorilux in 2010 based on evidence from two 8-week placebo controlled clinical trials in patients with mild to moderate plaque psoriasis of the body and one 8-week placebo controlled clinical trial in patients with moderate plaque psoriasis of the scalp. Further data was obtained in a follow-on open label study in patients aged 12 to 17 years of age with psoriasis.

Sorilux Foam contains calcipotriene, a synthetic vitamin D analog that has a similar receptor binding affinity as natural vitamin D. The exact mechanism of action contributing to the clinical efficacy is unknown.

Psoriasis is a chronic disease of the immune system affecting approximately 7.5 million Americans each year[1]. The most common form, plaque psoriasis affects roughly 80 percent of people who have the condition.

Mayne Pharma's CEO, Mr Scott Richards, said "Sorilux is an elegant foam formulation that is marketed by Mayne Pharma's Specialty Brands sales team alongside recently launched LEXETTE™ (halobetasol propionate) Foam, a potent topical corticosteroid also used to treat plaque psoriasis in adult patients. Topical products are the mainstay of treatment for plaque psoriasis patients and the foam delivery platform has a well-established reputation with dermatologists due to ease of application and lack of greasiness and stickiness, especially in hair-bearing areas and under clothing."

Mayne Pharma directly markets more than 60 products in the US including four branded dermatology products FABIOR® (tazarotene) Foam, Sorilux Foam, DORYX® MPC (doxycycline hyclate) delayed-release tablets and LEXETTE Foam. The Company also markets TOLSURA® (SUBA®-itraconazole) capsules used to treat certain fungal infections which was recently approved and launched this year.

https://en.wikipedia.org/wiki/Calcipotriol