EMA/CHMP recommends 6 new medicines and 3 generics for approval

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended 10 medicines for marketing authorization at its November 2015 meeting.

Among these Benepali (etanercept), a biosimilar of Amgen's Enbrel from Samsung Bioepis, received a positive opinion for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis and plaque psoriasis. The company is a joint venture between Samsung and US biotech firm Biogen Idec (Nasdaq: BIIB).

The CHMP recommended granting a marketing authorisation for Wakix (pitolisant) from Bioprojet Pharma for the treatment of narcolepsy. Narcolepsy is a rare, long-term sleep disorder which affects the brain’s ability to regulate the normal sleep-wake cycle, and may occur with or without cataplexy (sudden severe muscle weakness or loss of muscle control). Wakix, a first-in-class medicine, has an orphan designation. For more information, please see the press release in the grid below.