FDA Approves Two Supplemental Indications for Harvoni in Chronic Hepatitis C Patients With Advanced Liver Disease

In continuation of my update on Harvoni (ledipasvir/sofosbuvir)

Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved additional indications for Harvoni (ledipasvir/sofosbuvir) for use in chronic hepatitis C patients with advanced liver disease. Harvoni in combination with ribavirin (RBV) for 12 weeks was approved for use in chronic hepatitis C virus (HCV) genotype 1- or 4-infected liver transplant recipients without cirrhosis or with compensated cirrhosis (Child-Pugh A), and for HCV genotype 1-infected patients with decompensated cirrhosis (Child-Pugh B or C), including those who have undergone liver transplantation. Harvoni is now approved for use in a broader range of patient populations, including HCV genotypes 1, 4, 5 and 6, HCV/HIV-1 coinfection, HCV genotype 1 and 4 liver transplant recipients, and genotype 1-infected patients with decompensated cirrhosis..

FDA Approves Two Supplemental Indications for Harvoni in Chronic Hepatitis C Patients With Advanced Liver Disease

Arbor Pharmaceuticals Announces FDA Approval of Cetylev

Arbor Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) approved its New Drug Application (NDA) for Cetylev (acetylcysteine effervescent tablets for oral solution).  

(acetylcysteine)

Cetylev is an antidote for acetaminophen overdose indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in patients with acute ingestion or from repeated supratherapeutic ingestion. Acetaminophen overdose is the most common poisoning reported to emergency rooms in the United States. According to the American Association of Poison Control Centers there were 73,347 reported acetaminophen exposures in 2014 which resulted in 108 deaths.

Cetylev will be available in ready to use effervescent tablets intended to be mixed with water, resulting in a pleasant lemon-mint tasting solution. Currently, acetylcysteine solution is available in vials intended for inhalation which pharmacists typically mix with a diet cola for ingestion orally. It is also available in an intravenous dosage form which requires that patients be admitted into the hospital.

"For patients with acetaminophen overdose, it is critically important to administer acetylcysteine as quickly as possible to reverse or reduce potential fatal damage to the liver. Emergency rooms, ambulances and pharmacies will have a ready to use dosage form of acetylcysteine that can be administered quickly," said Ed Schutter, President and CEO of Arbor. "Cetylev adds to our growing portfolio of now nineteen different approved prescription products that may help to improve the lives of our patients."

Arbor Pharmaceuticals Announces FDA Approval of Cetylev

Study finds no beneficial effect of cancer medication on Alzheimer's disease

Bexarotene (brand name: Targretin) is an antineoplastic (anti-cancer) agent approved by the U.S.Food and Drug Administration (FDA) (in late 1999) and the European Medicines Agency (EMA) (early 2001) for use as a treatment for cutaneous T cell lymphoma (CTCL). It is a third-generation retinoid.

Study finds no beneficial effect of cancer medication on Alzheimer's disease: The cancer medication bexarotene, aka Targretin, made headlines when researchers reported that it quickly lowered Aβ in the brain, reduced amyloid plaques, and improved learning and memory in mice that mimic salient features of Alzheimer's disease (AD).

Impax Receives Approval of Emverm (mebendazole) Chewable Tablets

Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that the United States Food and Drug Administration (FDA) has approved the Company's supplemental new drug application (sNDA) for Emverm (mebendazole) 100 mg chewable tablets.

Impax Receives Approval of Emverm (mebendazole) Chewable Tablets

Allergan Announces FDA Approval of Updated Label for New Dosing Regimen for Dalvance (dalbavancin)

In continuation of my update on Dalbavancin

Allergan plc (NYSE: AGN), a leading global pharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has approved the company's supplemental new drug application (sNDA) to update the label for Dalvance (dalbavancin) for injection. The expanded label will include a single dose administered as a 30-minute intravenous (IV) infusion of Dalvance for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible Gram-positive bacteria in adults, including infections caused by methicillin-resistant Staphylococcus aureus (MRSA).

Allergan Announces FDA Approval of Updated Label for New Dosing Regimen for Dalvance (dalbavancin)

Adzenys XR-ODT (amphetamine) FDA Approval History

Neos Therapeutics, Inc. (Nasdaq:NEOS), a pharmaceutical company with a late‐stage pipeline of innovative extended-release (XR) product candidates for the treatment of attention-deficit/hyperactivity disorder (ADHD), today announced that the U.S. Food and Drug Administration (FDA) approved Adzenys XR-ODT for the treatment of ADHD in patients six years and older. With this approval, Adzenys XR-ODT is the first and only extended-release orally disintegrating tablet (ODT) for the treatment of ADHD.

“The novel features of an extended-release orally disintegrating tablet, which is dosed once daily and disintegrates in the mouth, make Adzenys XR-ODT attractive for use in both children (six years and older) and adults,” said Dr. Alice Mao, Medical Director, Memorial Park Psychiatry in Houston, TX.

Adzenys XR-ODT was approved by the FDA via the 505(b)(2) regulatory pathway. The clinical program demonstrated that Adzenys XR-ODT is bioequivalent to a previously approved mixed amphetamine salts extended-release capsule (Adderall XR¹), one of the most commonly prescribed medications for the treatment of ADHD. Adzenys XR-ODT will be available in six dosage strengths, equivalent to the Adderall XR¹ dosage strengths, thus allowing healthcare providers to individualize the dose.

Adzenys XR-ODT (amphetamine) FDA Approval History 

FDA Approves Halaven (eribulin mesylate) for the Treatment of Liposarcoma

The U.S. Food and Drug Administration today approved Halaven (eribulin mesylate), a type of chemotherapy, for the treatment of liposarcoma (a specific type of soft tissue sarcoma) that cannot be removed by surgery (unresectable) or is advanced (metastatic). This treatment is approved for patients who received prior chemotherapy that contained an anthracycline drug.

“Halaven is the first drug approved for patients with liposarcoma that has demonstrated an improvement in survival time,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “The clinical trial data the FDA reviewed indicates that Halaven increased overall survival by approximately seven months, offering patients a clinically meaningful drug.”

FDA Approves Halaven (eribulin mesylate) for the Treatment of Liposarcoma

FDA Approves Onzetra Xsail (sumatriptan nasal powder) for the Acute Treatment of Migraine

Sumatriptan is a medication used for the treatment of migraine headaches.It is a synthetic drug belonging to the triptan class. Structurally, it is an analog of the naturally occurring neuro-active alkaloidsdimethyltryptamine (DMT), bufotenine, and 5-methoxy-dimethyltryptamine, with an N-methyl sulfonamidomethyl- group at position C-5 on theindole ring.

Sumatriptan is produced and marketed by various drug manufacturers with many different trade names such as Imitrex, Imigran, and Treximetas a combination product with naproxen.

Avanir Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Onzetra Xsail (sumatriptan nasal powder), formerly known as AVP-825, for the acute treatment of migraine with or without aura in adults. Onzetra Xsail is an intranasal medication delivery system consisting of a low-dose (22mg) of sumatriptan powder that is delivered utilizing the novel Xsail™ Breath Powered Delivery Device. Onzetra Xsail is a fast-acting dry powder formulation of sumatriptan, the most commonly prescribed migraine medication.

“While there are many acute migraine treatment options available, more than 70% of patients are not fully satisfied with their current migraine treatment. Given this high dissatisfaction, there remains an unmet need to provide patients with fast-acting, well tolerated therapies that deliver consistent relief,” said Stewart Tepper, M.D., professor of neurology at the Geisel School of Medicine at Dartmouth.

“Onzetra Xsail provides a new and much needed treatment option for what can be a debilitating condition for millions of people,” said Roger K. Cady, M.D., director of the Headache Care Center and associate executive chairman of the National Headache Foundation. “The Xsail Breath Powered Delivery Device allows the medication to be deposited deep into the nose, an area that is rich with blood vessels. By delivering the medication here, Onzetra Xsail provides targeted and efficient delivery with the potential for fast, consistent relief, while also limiting the amount of medicine that goes down the back of the throat.”

“We are excited about this major milestone for Avanir as the approval of Onzetra Xsail represents our second approved product. We expect to make Onzetra Xsail available to patients in the coming months,” said Rohan Palekar, president and CEO of Avanir. “We continue to be focused on building a leading CNS biopharmaceutical company and the addition of Onzetra Xsail to our product portfolio takes us closer to achieving that goal.”

FDA Approves Onzetra Xsail (sumatriptan nasal powder) for the Acute Treatment of Migraine

FDA Approves Takeda's Dexilant SoluTab (dexlansoprazole)

Dexlansoprazole (INN, trade names Kapidex, Dexilant) is a proton pump inhibitor that is marketed by Takeda Pharmaceuticals for the treatment of erosive esophagitis and gastro-oesophageal reflux disease...

Takeda Pharmaceuticals U.S.A., Inc., (Takeda) (TSE: 4502) today announced that the United States (U.S.) Food and Drug Administration (FDA) approved Dexilant SoluTab delayed-release orally disintegrating tablets, a new formulation of dexlansoprazole that can be taken by allowing the tablet to melt in the patient's mouth. Dexilant SoluTab is a proton pump inhibitor (PPI) indicated for the treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) and the maintenance of healed erosive esophagitis (EE) and relief of heartburn in adults 18 years and older. Dexilant SoluTab is a PPI with dual delayed release (DDR) technology that is designed to provide two separate releases of medication.

FDA Approves Takeda's Dexilant SoluTab dexlansoprazole)

Promius Pharma Receives FDA Approval for Sernivo (betamethasone dipropionate) Spray

We know that Betamethasone dipropionate (see structure)  is a glucocorticoid steroid with anti-inflammatory and immunosuppressive abilities. It is applied as a topical cream, ointment, lotion or gel (Diprolene) to treat itching and other minor skin conditions such as eczema.

Brand names include Alphatrex, Beta-Val, Diprolene, Diprolene AF, Diprosone, and Luxiq.

Minor side effects include dry skin and mild, temporary stinging when applied.

Betamethasone dipropionate is a "super high potency" corticosteroid used to treat inflammatory skin conditions such as dermatitis, eczema andpsoriasis. It is a synthetic analog of the adrenal corticosteroids. Although its exact mechanism of action is not known, it is effective when applied topically to cortico-responsive inflammatory dermatoses...

Dr. Reddy’s announced today that its US subsidiary, Promius Pharma, LLC, U.S. (BSE: 500124, NSE: DRREDDY, NYSE: RDY), has received approval for Sernivo (betamethasone dipropionate) Spray, 0.05% from the U.S. Food and Drug Administration (FDA). Sernivo Spray, a prescription topical steroid, is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older. The commercial launch of the product is planned for the coming quarter.

Promius Pharma Receives FDA Approval for  ernivo (betamethasone dipropionate) Spray

FDA Approves Expanded Use of Daklinza (daclatasvir) for Additional Challenging-to-treat Patients with Genotype 1 or Genotype 3 Chronic Hepatitis C

In continuation  of my update on Daclatasvir

Bristol-Myers Squibb Company (NYSE:BMY) announced today that Daklinza (daclatasvir, 60 mg), an NS5A replication complex inhibitor, has been approved by the U.S. Food and Drug Administration (FDA) in combination with sofosbuvir (with or without ribavirin) in genotypes 1 and 3. The expanded label includes data in three additional challenging-to-treat patient populations: chronic hepatitis C virus (HCV) patients with HIV-1 coinfection, advanced cirrhosis, or post-liver transplant recurrence of HCV. The Daklinza plus sofosbuvir regimen is already available for the treatment of chronic HCV genotype 3, and is currently the only 12-week, once-daily all-oral treatment option for these patients. Sustained virologic response (SVR) rates are reduced in genotype 3 patients with cirrhosis receiving Daklinza and sofosbuvir for 12 weeks without ribavirin. The recommended dosage of Daklinza is 60 mg in combination with sofosbuvir with or without (+/-) ribavirin for 12 weeks..

“The expanded indication for Daklinza offers an additional treatment option for multiple subsets of patients who have genotype 1 or 3 chronic HCV,” said Chris Boerner, Head of U.S. Commercial, Bristol-Myers Squibb. “HCV/HIV-coinfected patients and patients with advanced cirrhosis or post-transplant recurrence of HCV still pose a treatment challenge to physicians. As part of our commitment to the HCV community, we have sought to make new treatment options available for these and other targeted populations that have not yet been able to fully benefit from currently available next-generation medicines.”

FDA Approves Expanded Use of Daklinza (daclatasvir) for Additional Challenging-to-treat Patients with Genotype 1 or Genotype 3 Chronic Hepatitis C

Ambrisentan avoids sildenafil drug interaction in PAH patients

Sildenafil may be better given to pulmonary arterial hypertension patients in combination with ambrisentan than with bosentan, study findings suggest.

 (Ambrisentan)   (Sildenafil)

Sildenafil may be better given to pulmonary arterial hypertension (PAH) patients in combination with ambrisentan than with bosentan, study findings suggest.Researcher Keiichi Odagiri (Hamamatsu University School of Medicine, Japan) and team found that patients’ plasma concentration of sildenafil was significantly lower if given with bosentan, compared with ambrisentan.

They say this is because bosentan induces the expression of cytochrome P450 3A4, thus interfering with the pharmacokinetics of sildenafil. Ambrisentan has no such effect, so when the seven study patients, who were all taking sildenafil, were switched from bosentan to ambrisentan, their plasma concentrations of sildenafil were significantly higher.

The patients attained maximum sildenafil concentration in 1.0 hours when they took it with ambrisentan, compared with 0.5 hours with bosentan, and their respective maximum plasma concentrations were 120.2 versus 58.3 ng/mL.And the corresponding areas under the plasma concentration–time curve, representing plasma concentrations across 8 hours, were 396.8 versus 165.8 ng/h per mL.

The team notes that the patients received bosentan 62.5 mg twice daily, rather than the usually recommended 125.0 mg twice daily. They explain that Japanese physicians often use this dose “because of concerns about dose-dependent hepatic toxicity, even though the pharmacokinetics of bosentan and its metabolites are broadly comparable in Japanese and Caucasian individuals.”

Patients’ exercise tolerance improved in line with the higher sildenafil levels achieved with ambrisentan versus bosentan, the researchers report in Clinical and Translational Science.

The median distance achieved in the externally paced 10-metre shuttle walking test was significantly greater during 4–5 weeks of ambrisentan treatment than during the equivalent time on bosentan, at 340 versus 280 metres. The corresponding median 6-minute walking distances were not significantly different, at 503.0 versus 454.0 metres, but peak oxygen consumption and oxygen consumption at anaerobic threshold were significantly greater during the ambrisentan versus bosentan treatment periods.

The researchers caution, however, that they did not use invasive haemodynamic measures to definitively measure treatment response.

Ambrisentan avoids sildenafil drug interaction in PAH patients:

Positive data on ability of MyoKardia’s MYK-461 to prevent development of HCM

Positive data on ability of MyoKardia’s MYK-461 to prevent development of HCM  

MyoKardia, Inc., a clinical stage biopharmaceutical company pioneering a precision medicine approach for the treatment of heritable cardiovascular diseases, today announced the publication of an article in the leading medical journal Science. The article demonstrates the ability of MYK-461, the company’s lead drug candidate, to prevent and reverse development of disease in multiple genetic mouse models of hypertrophic cardiomyopathy (HCM). The published research represents the product of collaboration among scientists from MyoKardia, Harvard Medical School, the University of Colorado and Stanford University. These data add to a growing body of laboratory and clinical research demonstrating the potential of MYK-461 as an important and novel approach to treating HCM.

The study, titled “A Small-Molecule Inhibitor of Sarcomere Contractility Suppresses Hypertrophic Cardiomyopathy in Mice,” will be published in the Feb. 5 issue of the journal Science.

“I am encouraged by these data that illustrate MYK-461’s ability to effectively reduce the consequences of HCM mutations at the biochemical, cellular and whole animal levels,” said Jonathan Fox, M.D., Ph.D., chief medical officer of MyoKardia. “Translation of these findings from mouse to human could offer great potential to improve the lives of patients living with this devastating disease.”

Bosutinib shows 'low' vascular, cardiac event risk profile

 In continuation of my update on Bosutinib

Third-generation tyrosine kinase inhibitor (TKI) study findings suggest that bosutinib is associated with a low risk of vascular and cardiac events in patients undergoing first-line or subsequent treatment for chronic myeloid leukaemia (CML).

"The results of this analysis suggest that the vascular and cardiac toxicity profile of bosutinib is distinct relative to other TKIs", write Jorge Cortes, from University of Texas MD Anderson Cancer Center in Houston, USA, and co-authors in the American Journal of Hematology

.

The team collated information on treatment-emergent adverse events (TEAEs) in 570 patients who received second-, third- or fourth-line bosutinib treatment for Philadelphia chromosome-positive CML as part of a phase I/II study.

In addition, the researchers determined the incidence of TEAEs in a phase III study comparing first-line bosutinib in 248 patients with first-line imatinib in 251 patients.

Trial participants were all followed up for at least 2 years and the overall incidence of vascular TEAEs was low, with all-grade and grade 3 or more severe side effects affecting 6.8% and 3.7% of patients given bosutinib, respectively.

First-line bosutinib was associated with a lower rate of vascular TEAEs than second-line or subsequent bosutinib therapy, affecting 4.8% versus 7.7%. First-line imatinib had comparable incidence of both overall and grade 3 and more severe vascular TEAEs to that of first-line bosutinib.

Cerebrovascular TEAEs were reported in 1.8% of patients given bosutinib, again being less common in those given primary bosutinib relative to second-line or later treatment (0.8 vs 2.3%). All-grade and grade 3 or more severe cardiovascular TEAEs occurred in 3.7% and 2.3% of bosutinib-treated patients, occurring at a lower rate in first-line than later treated patients (2.4 vs 4.2%).

Serious vascular TEAEs were reported in 4.2% of bosutinib-treated patients, with grade 3 or more severe events occurring in 3.1%, most commonly coronary artery disease (0.9%) and acute myocardial infarction (0.6%).

Events were less common in newly diagnosed patients than those with refractory or relapsed disease (2.0 vs 5.1%), and there was no significant difference in the incidence or exposure-adjusted rate between the first-line bosutinib and imatinib groups.

Ref : http://onlinelibrary.wiley.com/doi/10.1002/ajh.24360/abstract

Bosutinib shows 'low' vascular, cardiac event risk profile: Third-generation tyrosine kinase inhibitor study findings suggest that bosutinib is associated with a low risk of vascular and cardiac events in patients undergoing first-line or subsequent treatment for chronic myeloid leukaemia.

EC approves expanded use of Daklinza (daclatasvir) for patients with chronic HCV and HIV co-infection

Daclatasvir formerly BMS-790052, trade name Daklinza) is a drug for the treatment of hepatitis C (HCV). It was developed by Bristol-Myers Squibb and was approved in Europe on 22 August 2014. Daklinza gained its FDA approval on July 24, 2015 in the United States; it is approved for Hepatitis C genotype 3 infections.  

A generic version of daclatasvir is expected to be approved in India before the end of 2015. 

Daclatasvir inhibits the HCV nonstructural protein NS5A.  Recent research suggests that it targets two steps of the viral replication process, enabling rapid decline of HCV RNA. Daclatasvir has been tested in combination regimens with pegylated interferon and ribavirin,  as well as with other direct-acting antiviral agents including asunaprevir and sofosbuvir....

Now....

EC approves expanded use of Daklinza (daclatasvir) for patients with chronic HCV and HIV co-infection: Bristol-Myers Squibb today announced that the European Commission has approved the expanded use of Daklinza, a first-in-class oral, once-a-day pill used in combination with other treatments as an option for adult patients with chronic hepatitis C virus infection who are co-infected with HIV or who have had a prior liver transplant.