Dr. Roy Baynes
MSD Provides Update on European Medicines Agency Marketing Authorisation Application for Investigational Chronic Hepatitis C Therapy Elbasvir/Grazoprevir
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.