May 20 2011
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion under accelerated assessment recommending approval of the investigational medicine VICTRELISTM (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.
“What should I tell my healthcare provider before taking VICTRELIS?”
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.
"We are pleased with CHMP's recommendation to approve VICTRELIS in combination with current standard therapy," said Peter S. Kim, Ph.D., president, Merck Research Laboratories. "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."
The CHMP positive opinion for VICTRELIS in combination with current standard therapy is based on the efficacy and safety results from two large Phase III clinical studies conducted at EU and U.S. sites that evaluated approximately 1,500 adult patients with chronic HCV genotype 1 infection. The HCV SPRINT-2 study involved 1,097 patients who were new to treatment (treatment naïve) and the HCV RESPOND-2 study involved 403 patients who had failed previous therapy. Final results of the studies were published in the New England Journal of Medicine on March 31, 2011.
VICTRELIS is a Direct Acting Antiviral (DAA) agent designed to interfere with the ability of the hepatitis C virus to replicate by inhibiting a key viral enzyme (NS3/4A serine protease).