EMA Smiles on 6 Medicines for Marketing Authorization

The EMA’s Committee for Medicinal Products for Human Use has recommended six new medicines for marketing authorization, including three innovators and three generics.

The committee gave a positive opinion for Bristol-Myers Squibb’s Empliciti under accelerated assessment. It is used in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma. Empliciti was approved by the FDA in November 2015 for the same indication.

Also reviewed under accelerated assessment was Bio Products Laboratory’s Coagadex, which nabbed a positive opinion for the treatment and prophylaxis of bleeding episodes, as well as the perioperative management in patients with hereditary factor X deficiency. The FDA approved the biologic for hereditary factor X deficiency in October 2015.

In addition, the committee gave a positive opinion for Actelion Pharmaceuticals’ Uptravi to treat pulmonary arterial hypertension. Uptravi snagged FDA approval for the same indication last December.

The committee also recommended three generic medications from Mylan: amlodipine-valsartan combo for the treatment of essential hypertension, Rasagiline for the treatment of idiopathic Parkinson’s disease and Zonisamide for the treatment of partial seizures, with or without secondary generalization.