Gilead's Epclusa And Merck's Zepatier Hep C Combos Get EMA backing

The European Medicines Agency is recommending EU marketing approval for Gilead Sciences Inc.'s Epclusa (sofosbuvir/velpatasvir) and Merck & Co. Inc.'sZepatier (grazoprevir/elbasvir) after the two doublet therapies were backed by EMA's Committee for Medicinal Products for Human Use (CHMP). Europe's top drug regulator on May 27 said the two regimes allow cure of patients with long-term hepatitis C virus infection without the need for interferons, which are associated with poor tolerability and potentially serious side effects.

Epclusa and Zepatier belong to a new generation of medicines for chronic HCV infection, direct-acting antivirals, that give high rates...