Pharma News

The RE-DUAL PCI™ trial explored anticoagulation with Pradaxa® (dabigatran etexilate) dual therapy without aspirin in non-valvular atrial fibrillation (AF) patients following percutaneous coronary intervention (PCI) and stent placement: results showed significantly lower rates of major or clinically relevant non-major bleeding events for dual therapy with Pradaxa® when compared to triple therapy with warfarin.1,2 The risk for the primary safety endpoint was 48% lower for Pradaxa® 110 mg dual therapy and 28% lower for Pradaxa® 150 mg dual therapy (relative difference), with similar rates of overall thromboembolic events. Both Pradaxa® doses have been approved by regulatory authorities around the world for stroke prevention in AF. The results were presented today as a late-breaker at the ESC Congress 20171 and have been simultaneously published in the New England Journal of Medicine.

Abeona Therapeutics Inc a leading clinical-stage biopharmaceutical company focused on developing novel gene therapies for life-threatening rare diseases, announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy designation status to the Company’s EB-101 gene therapy program for patients with Recessive Dystrophic Epidermolysis Bullosa (RDEB).  The designation from the FDA enables collaborative discussions with senior FDA personnel, priority review and an expedited approval process to drug candidates where preliminary clinical trials indicate that a therapy may offer substantial treatment advantages over existing options for patients with serious or life-threatening diseases.

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Pierre Fabre Laboratories the 2nd largest private French pharmaceutical group announced that the European Medicines Agency (EMA) has validated the review of the Marketing Authorization Applications (MAAs) for the use of the combination of binimetinib 45 mg twice daily and encorafenib 450 mg once daily (COMBO450) for the treatment of patients with BRAF-mutant advanced, unresectable or metastatic melanoma. The submissions are supported by data from the pivotal Phase 3 COLUMBUS study, which showed that patients who received the combination of binimetinib and encorafenib had a significantly longer progression free survival (PFS) compared to patients receiving vemurafenib.

Dr. Reddy’s Laboratories Ltd. announced that it has launched Cefixime for Oral Suspension, USP 100 mg/5mL and 200 mg/5mL, a therapeutic equivalent generic version of Suprax® (cefixime) for Oral Suspension, approved by the U.S. Food and Drug Administration (USFDA).

Bristol-Myers Squibb Company and Pfizer Inc. presented findings from EMANATE (Eliquis evaluated in acute cardioversion coMpared to usuAl treatmeNts for AnTicoagulation in subjEcts with NVAF), a Phase 4 clinical trial, during a late-breaking hot line presentation at the ESC Congress 2017, organized by the European Society of Cardiology, in Barcelona, Spain. This descriptive, randomized, open-label trial explored the safety and efficacy of apixaban 5 mg twice daily (2.5 mg lower dose when two of the following were present: age ≥80 years, weight ≤60 kg, or serum creatinine ≥1.5 mg/dL (133μmol/L)) vs. standard of care (parenteral heparin and/or vitamin K antagonist). The outcomes measured in this study were the occurrence of acute stroke, systemic embolism, major bleeding, clinically relevant non-major bleeding and all-cause death in non-valvular atrial fibrillation patients undergoing cardioversion. This is an investigational use for Eliquis. Eliquis is not FDA-approved for the reduction of stroke in NVAF patients undergoing cardioversion (please see indications and important safety information for Eliquis later in the press release).

AVEO Oncology announced that the European Commission (EC) has approved FOTIVDA® (tivozanib) for the treatment of adult patients with advanced renal cell carcinoma (RCC) in the European Union plus Norway and Iceland. Tivozanib is indicated for the first line treatment of adult patients with advanced RCC and for adult patients who are vascular endothelial growth factor receptor (VEGFR) and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy for advanced RCC.i EUSA Pharma, a specialty pharmaceutical company with a focus on oncology and oncology supportive care, is the European licensee for tivozanib. Tivozanib is an oral, once-daily, potent and highly-selective vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI).

Boehringer Ingelheim and pharmaceutical company Pharmaxis announce that Boehringer Ingelheim has initiated a European and North American Phase IIa trial in NASH with BI 1467335 (formerly known as PXS-4728A), acquired from Pharmaxis in May 2015. The compound is an oral inhibitor of amine oxidase, copper containing 3 (AOC3)1, and works by blocking leucocyte adhesion and tissue infiltration in inflammatory processes underlying NASH.

Zealand Pharma A/S ("Zealand") reports that Boehringer Ingelheim has announced the initiation of two Phase 1 trials, the first with a glucagon/GLP-1 agonist that has the potential for once-weekly administration for the treatment of obesity and/or type 2 diabetes and the second with a novel differentiated long-acting amylin analog for the treatment of obesity and/or diabetes.

Zydus Cadila has received the final approval from the USFDA to market Candesartan Cilexetil Tablets USP and Ziprasidone Hydrochloride Capsules

Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) and granted Priority Review for emicizumab prophylaxis (preventative) as a once-weekly subcutaneous treatment for adults, adolescents and children with hemophilia A with factor VIII inhibitors. Nearly one in three people with hemophilia A develop inhibitors to standard factor VIII replacement therapies, which limits treatment options and increases the risk of life-threatening bleeds and repeated bleeds, particularly in joints, that cause long-term damage.