MSD (NYSE: MRK), known as Merck in 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 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 authorisation 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 boceprevir in combination with current standard therapy,” said Peter S. Kim, Ph.D., president, Merck Research Laboratories. “If approved, boceprevir would represent the first in a new class of medicines known as HCV protease inhibitors and offer an important new treatment option for patients with chronic hepatitis C genotype 1."
Boceprevir 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). It was approved by the U.S. Food and Drug Administration on 13 May, 2011 for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients (18 years of age and older) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy.
The CHMP positive opinion 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 31 March, 2011.
Notes to Editor
MSD's global commitment to advancing hepatitis therapy
MSD is committed to building on its strong legacy in the field of viral hepatitis by continuing to discover, develop and deliver vaccines and medicines to help prevent and treat viral hepatitis. In hepatitis C, company researchers developed the first approved therapy for chronic HCV in 1991 and the first combination therapy in 1998. In addition to ongoing studies with boceprevir, extensive research efforts are underway to develop additional innovative oral therapies for viral hepatitis treatment.
About MSD
Today's MSD is a global healthcare leader working to help the world be well. MSD is a tradename of Merck & Co., Inc., with headquarters in Whitehouse Station, N.J., U.S.A. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.msd.com&esheet=6731893&lan=en-US&anchor=www.msd.com&index=1&md5=718fd54380ce9df46329ee4dc9f5b0b6.
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1 Accelerated assessment was introduced by the revised EU pharmaceutical legislation in November 2005. The aim of this new regulatory tool is to help speed up access of patients to new medicines of major public-health interest. Companies can request accelerated assessment provided they are able to demonstrate that their product responds to unmet medical needs or constitutes a significant improvement over the available methods of prevention, diagnosis or treatment of a condition.
VICTRELIS® is a registered trademark of Schering Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, N.J., USA.
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