The Committee for Medicine Products for Human Use (CHMP) branch of the European Medicines Agencies (EMA) recently granted a positive opinion of Zepatier, a Merck product.
Merck, called MSD outside of Canada and the U.S., now has recommending approval from CHMP for its once-daily, investigational, fixed-dose combination tablet that is designed to treat chronic hepatitis C virus (HCV) among adult patients.
Soon, the European Commission (EC) will review the positive opinion from CHMP. After that, the EC will give a centralized marketing authorization with unified labeling. This will be eligible within the entire European Union and European Economic Area member states Liechtenstein, Iceland and Norway.
“We are pleased with the CHMP’s positive opinion recommending the marketing authorization of Zepatier in the European Union, which marks an important step forward in the European regulatory process,” Roy Baynes, head of clinical development for Merck Research Laboratories, said. “Our application was based on the findings from a broad clinical development program evaluating the efficacy and safety of Zepatier across diverse populations of patients with chronic hepatitis C, including patients with compensated cirrhosis and those with stage-four or five chronic kidney disease.”
Merck’s hope is to gain the EC’s decision by the middle of this year. Then the company hopes to gain manufacturing readiness for the EU market during the fourth quarter of this year, or the first quarter of 2017.
