EMA names first therapies in PRIME scheme

EMA has accepted four therapies into its PRIority MEdicines (PRIME) scheme, the agency's equivalent to FDA's Breakthrough Therapy designation. The four are aducanumab ( BIIB037) from Biogen Inc. (NASDAQ:BIIB), CCX168 from ChemoCentryx Inc. (NASDAQ:CCXI), KTE-C19 from Kite Pharma Inc. (NASDAQ:KITE) and NI-0501 from Novimmune S.A. (Plan-les-Ouates, Switzerland).

Aducanumab, a human recombinant anti-beta amyloid mAb, is in Phase III testing to treat Alzheimer's disease. CCX168, a small molecule complement receptor 5a (C5aR; CD88) inhibitor, is in Phase II testing to treat antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis. ...