EMA recommends approval of direct-acting antivirals Epclusa and Zepatier

The European Medicines Agency has recommended the granting of marketing authorizations in the European Union for two new combination therapies against chronic (long-term) hepatitis C virus (HCV) infection, Epclusa (sofosbuvir/velpatasvir) and Zepatier (grazoprevir/elbasvir).

Epclusa, from US biotech giant Gilead Sciences (Nasdaq: GILD) and Zepatier from pharma major Merck & Co (NYSE: MRK), belong to a new generation of medicines for chronic HCV infection, direct-acting antivirals, that give high rates of cure of HCV infection and that have, in the past few years, reshaped the way this disease is treated. These medicines block the action of proteins which are essential for viral replication. Epclusa targets the proteins NS5B and NS5A, while Zepatier targets the proteins NS3/4A and NS5A.

HCV infection is a major European public health challenge. It affects between 0.4% and 3.5% of the population in different EU member states and is the most common single cause of liver transplantation in the region.