Merck (NYSE:MRK), known as MSD outside 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 authorization 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 Merck that the application will now be reviewed on a standard timetable, rather than the accelerated assessment timeline previously announced. Under the revised timeline, Merck 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,” said Dr. Roy Baynes, senior vice president and head of global clinical development, Merck Research Laboratories.