27 May 2016 - Direct-acting antivirals Epclusa and Zepatier recommended for approval.

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

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.

Epclusa and Zepatier 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.

For more details, go to: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/05/news_detail_002537.jsp&mid=WC0b01ac058004d5c1