Merck, known as MSD outside the United States and Canada, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion under accelerated assessment1 recommending approval of the investigational medicine VICTRELIS™ (boceprevir) for the treatment of chronic hepatitis C virus (HCV) genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy.
The positive opinion will be reviewed by the European Commission, which grants marketing authorization with unified labeling that is valid in the 27 countries that are members of the European Union (EU), as well as European Economic Area members, Iceland, Liechtenstein and Norway.
Peter S. Kim, Ph.D., president, Merck Research Laboratories said, We are pleased with CHMP’s recommendation to approve VICTRELIS in combination with current standard therapy. If approved, VICTRELIS would represent the first in a new class of medicines known as HCV protease inhibitors granted marketing authorization in the European Union, and would offer an important new treatment option for patients with chronic hepatitis C genotype 1
