(RTTNews) - Healthcare giant Merck & Co. Inc. (MRK: News ) Friday stated that a committee of European Medicines Agency has issued a positive opinion, recommending approval of its investigational hepatitis C drug victrelis in combination with current standard therapy.
Victrelis, also known as boceprevir, is a direct acting antiviral agent designed to interfere with the ability of the hepatitis C virus to replicate by inhibiting a key viral enzyme (NS3/4A serine protease).
Victrelis is being investigated in combination with peginterferon alfa and ribavirin for the treatment of chronic hepatitis C virus (HCV) genotype 1 infection in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy.
New Jersey-based Merck said that the European Medicines Agency's Committee for Medicinal Products for Human Use or CHMP adopted the positive opinion on victrelis under an accelerated assessment, which was introduced by the EU in November 2005 to help speed up access to new medicines of major public-health interest.
The CHMP's recommendation for victrelis was based on efficacy and safety results from two large Phase III clinical studies conducted in EU and the U.S. These studies evaluated about 1,500 adult patients with chronic HCV genotype 1 infection.
The company has published the final results of the studies in the New England Journal of Medicine on March 31.
The European Commission will review CHMP's positive opinion and will grant marketing authorization with unified labeling that is valid in the 27 EU member countries as well as European Economic Area members, Iceland, Liechtenstein and Norway.
Victrelis is currently available in the U.S. following its approval by the U.S. FDA on May 13.
MRK closed Thursday's trading at $37.38, down $0.30, on a volume of 11.36 million shares.
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