Merck Gets Positive CHMP Opinion For ZEPATIER In EU

(RTTNews) - Merck & Co. Inc. (MRK) said that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency or EMA has adopted a positive opinion recommending approval of ZEPATIER (elbasvir and grazoprevir), an investigational, once-daily, fixed-dose combination tablet for the treatment of chronic hepatitis C virus or HCV in adult patients.

The CHMP positive opinion will be reviewed by the European Commission. If the European Commission affirms the CHMP opinion, it will grant a centralized marketing authorization with unified labeling that is valid in the 28 countries that are members of the European Union, as well as European Economic Area members, Iceland, Liechtenstein and Norway. Merck anticipates that the European Commission decision will be made in mid-2016.

The company said it continues to work to achieve manufacturing readiness to supply the EU market, with product launches estimated to begin in the fourth quarter of 2016 or the first quarter of 2017.

The U.S. Food and Drug Administration and Health Canada approved ZEPATIER 50mg/100mg tablets in January 2016. In the United States, ZEPATIER is indicated for the treatment of adult patients with chronic HCV genotype 1 or 4 infection, with or without ribavirin (RBV).