Merck receives positive CHMP opinion for Zepatier (elbasvir and grazoprevir) in the EU
Product launches estimated to begin in the fourth quarter of 2016 or the first quarter of 2017.
Merck (MSD) 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), an investigational, once daily, fixed-dose combination tablet for the treatment of chronic hepatitis C virus (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 EU, 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 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 FDA and Health Canada approved Zepatier 50 mg/100 mg tablets in January 2016. In the US, Zepatier is indicated for the treatment of adult patients with chronic HCV genotype 1 or 4 infection, with or without ribavirin (RBV). “We are pleased with the CHMP’s positive opinion recommending the marketing authorization of Zepatier in the EU, which marks an important step forward in the European regulatory process,” said Dr Roy Baynes, senior vice president and head of clinical development, Merck Research Laboratories. “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.”
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