MSD (NYSE: MRK), known as Merck in the United States and Canada, announced today that the European Medicines Agency (EMA) has granted marketing authorisation to 'Victrelis'(boceprevir), the first licensed product in a new class of medicines to treat hepatitis C. Boceprevir is indicated to treat chronic hepatitis C (CHC) 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.

Boceprevir is the first direct acting antiviral agent targeting the hepatitis C virus, to be licensed by the European Medicines Agency (EMA). It works by interfering with viral replication by inhibiting a key viral enzyme (NS3 serine protease). Boceprevir was authorised using an accelerated assessment due to its major public-health interest. It now has unified labelling, valid in the 27 European Union (EU) member state countries, as well as European Economic Area members, Iceland, Liechtenstein and Norway.

"We are delighted the EMA has granted marketing authorisation to boceprevir in combination with current standard therapy," said Paul Robinson, Medical Director UK. "Boceprevir represents the first licensed drug in a new class of medicines and the first drug to be granted marketing authorisation for HCV treatment in 10 years. MSD is proud to deliver innovative health solutions and provide a new treatment option for patients with chronic hepatitis C genotype 1."

The EMA decision 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.1A,2A The HCV SPRINT-2 study involved 1,097 patients who were new to treatment ('treatment-naïve')1A and the HCV RESPOND-2 study involved 403 patients who had failed previous therapy.2A Final results of the studies were published in the New England Journal of Medicine on March 31, 2011. Boceprevir, in combination with standard of care, showed encouraging statistically significant improvements in sustained virological responses or cure rates compared to standard of care alone, with a manageable toxicity and side effect profile.1B,2B

Notes

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 licensed 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.

References

1. Poordad, F. Boceprevir for Untreated Chronic HCV Genotype 1 Infection. N Engl J Med Vol. 364;13, 1195-1206.

2. Bacon, B. Boceprevir for Previously Treated Chronic HCV Genotype 1 Infection. N Engl J Med 2011. 364;13,1207-1217.

Source:
MSD