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news.Merck has received positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for its experimental drug Victrelis (boceprevir) as a treatment for chronic hepatitis C virus (HCV) genotype 1 infection.
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The CHMP’s opinion was for the combination of Victrelis with peginterferon alfa and ribavirin, in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy.
The decision was based on the positive and safety results from the two Phase III trials assessed 1,500 adult patients with chronic HCV genotype 1 infection.
Merck Research Laboratories president Peter Kim said if approved, Victrelis would represent the first in a new class of medicines known as HCV protease inhibitors granted marketing authorization in the EU, and would offer an important new treatment option for patients with chronic hepatitis C genotype 1.