EMA/CHMP recommends eight new drugs for approval, including five orphans

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended eight new medicines for approval at its July meeting, and rejected two.

The CHMP recommended granting a marketing authorization for Japanese drugmaker Santen’s (TYO: 4536) Verkazia (ciclosporin), an orphan medicine to treat severe vernal keratoconjunctivitis in children and adolescents. This medicine was reviewed under EMA’s accelerated assessment mechanism. There is a need for additional treatments because currently authorised therapies are not always effective or adequate to control severe VKC, the CHMP noted.

Four other orphan medicines were recommended for approval by the Committee: German company Merck KGaA’s (MRK: DE) Bavencio (avelumab) for the treatment of Merkel cell carcinoma; French firm Advanced Accelerator Applications’ Lutathera (lutetium [177Lu] oxodotreotide), for the treatment of gastro-entero-pancreatic neuroendocrine tumours; Swiss pharma giant Novartis’ (NOVN: VX) Rydapt (midostaurin), for the treatment of acute myeloid leukemia, aggressive systemic mastocytosis, systemic mastocytosis with associated haematological neoplasm and mast cell leukemia. If approved, Rydapt would be the first and only EMA-approved therapy for advanced SM, a group of rare, life-threatening conditions; and French drugmaker Ipsen Pharma’s (Euronext: IPSEY) Xermelo (telotristat ethyl), for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analogue (SSA) therapy in adults inadequately controlled by SSA therapy.