European approval for Merck's hepatitis C drug Zepatier

The European Commission has approved US pharma giant Merck & Co’s (NYSE: MRK) Zepatier (elbasvir/grazoprevir) with or without ribavirin (RBV) for the treatment of chronic hepatitis C virus (HCV) genotype (GT) 1 or GT4 infection in adults.

This approval allows marketing of Zepatier tablets in the 28 countries that are members of the European Union, as well as European Economic Area members, Iceland, Liechtenstein and Norway. Merck continues to work to supply the EU market, with product launches estimated to begin between the fourth quarter of 2016 and the first quarter of 2017. Product launches are expected to continue across the EU through 2017.

“The approval of Zepatier in the European Union, following approvals in the United States and Canada earlier this year, is an important step in offering a new and effective treatment for millions of people infected with hepatitis C virus genotype 1 or 4,” said Dr Roger Perlmutter, president, Merck Research Laboratories, a USA-based division of Merck. “Zepatier is the most recent advance from MSD [Merck & Co’s trading name outside of North America] in our more than 30-year effort to combat the effects of hepatitis C virus infection, and hence, to reduce the burden of this disease around the world,” he added.