August 2017

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).