Posted by Michael Wonder on 23 Jul 2017
Highlights from the CHMP 17-20 July 2017 meeting
21 July 2017 - Eleven medicines recommended for approval, including five orphans.
The European Medicines Agency’s CHMP recommended eleven medicines for approval at its July meeting.
The CHMP recommended granting a marketing authorisation for Verkazia (ciclosporin), an orphan medicine to treat severe vernal keratoconjunctivitis in children and adolescents. This medicine was reviewed under EMA’s accelerated assessment mechanism.
Four other orphan medicines were recommended for approval by the Committee: Bavencio (avelumab) for the treatment of Merkel cell carcinoma; Lutathera (lutetium [177Lu] oxodotreotide), for the treatment of gastro-entero-pancreatic neuroendocrine tumours; Rydapt (midostaurin), for the treatment of acute myeloid leukaemia, aggressive systemic mastocytosis, systemic mastocytosis with associated haematological neoplasm and mast cell leukaemia; and Xermelo (telotristat ethyl), for the treatment of carcinoid syndrome.
