Merck & Co. Provides Update On European Medicines Agency Marketing Authorisation Application For Investigational Chronic Hepatitis C Therapy Elbasvir/Grazoprevir

KENILWORTH, N.J.--(BUSINESS WIRE)--MSD, known as Merck (NYSE:MRK) 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 responded to the company’s marketing authorisation application (MAA) for elbasvir/grazoprevir (50mg/100mg), which is under review for the treatment of adult patients with chronic hepatitis C (HCV) infection. The CHMP advised MSD that the application will now be reviewed on a standard timetable, rather than the accelerated assessment timeline previously announced. Under the revised timeline, MSD anticipates a European Commission decision in mid-2016.

“We are excited about the potential of elbasvir/grazoprevir and look forward to continuing our discussions with the European Medicines Agency to bring this important medicine to appropriate patients with chronic hepatitis C in the European Union”

“We are excited about the potential of elbasvir/grazoprevir and look forward to continuing our discussions with the European Medicines Agency to bring this important medicine to appropriate patients with chronic hepatitis C in the European Union,” said Dr. Roy Baynes, senior vice president and head of global clinical development, Merck Research Laboratories, a U.S.-based division of Merck & Co., Inc., Kenilworth, N.J., USA.

About MSD

Today’s MSD is a global health care leader working to help the world be well. MSD is a tradename of Merck & Co., Inc., with headquarters in Kenilworth, N.J., USA. Through our prescription medicines, vaccines, biologic therapies, 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.

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