FDAnews
www.fdanews.com/articles/175567-ema-recommends-6-new-drugs-for-marketing-authorization

EMA Recommends 6 New Drugs for Marketing Authorization

March 3, 2016

Six new drugs scored wins at the European Medicines Agency, scooping up recommendations for marketing authorization from the Committee for Medicinal Products for Human Use.

Two hemophilia B drugs to treat bleeding were among the victors: Biogen’s Alprolix and CSL Behring’s Idelvion. Both drugs have orphan designations.

Additionally, Taiho Oncology’s Lonsurf for the treatment of metastatic colorectal cancer, Gilead’s Descovy for the treatment of HIV infection and Eli Lilly’s Taltz for the treatment of plaque psoriasis nabbed positive opinions from the committee. Lonsurf is the only product with FDA approval.