Merck & Co., Inc. (NYSE: MRK) disclosed Friday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has provided a positive opinion recommending its approval of ZEPATIER. The drug is an investigational, once-daily, fixed-dose combination tablet for chronic hepatitis C virus (HCV) treatment in adult patients.
Merck said that the CHMP positive opinion would be reviewed by the European Commission. The company indicated that if the European Commission affirmed the CHMP opinion, it would grant a centralized marketing authorization with unified labeling. As a result, it would become valid in the 28 countries that are members of the European Union, as well as European Economic Area members, Iceland, Liechtenstein and Norway.
The drug maker said that it expects the European Commission to take a decision in mid-2016. The company added that it continued to work to achieve manufacturing readiness to supply the EU market as the product launches are expected to commence in the fourth quarter of the current year or the first quarter of the next year.
Merck said that the FDA in the United States and Health Canada approved ZEPATIER 50mg/100mg tablets in January last. 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).
The company's SVP and Head of clinical development, Roy Baynes, commented, "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."
He added, "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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