May 27, 2016
Merck has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of ZEPATIER™ (elbasvir and grazoprevir). This is an investigational, once-daily, fixed-dose combination tablet that is used for the treatment of adult patients suffering from chronic hepatitis C virus (grazoprevir).
The European Commission will review this opinion from the CHMP. If the Commission affirms the CHMP opinion, it will grant a centralized marketing authorization with unified labelling. This is valid in the 28 countries that European Union members, as well as European Economic Area members, Iceland, Norway, and Liechtenstein. Merck expects that the decision of the European Commission will be made in mid-2016. The company also estimates that the product launches will start in the fourth quarter of 2016 or the first quarter of 2017.
As commented by Dr. Roy Baynes, senior vice president and head of clinical development, Merck Research Laboratories: “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. 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 4 or 5 chronic kidney disease.”