Grazoprevir/elbasvir single tablet combo filed in EU for hepatitis C genotypes 1, 3, 4 or 6 - Merck Inc

Merck Inc announced the European Medicines Agency has accepted for review a marketing authorization application for grazoprevir/elbasvir (100mg/50mg), an investigational, once-daily, single-tablet combination therapy for the treatment of adult patients with chronic hepatitis C (HCV) genotypes (GT) 1, 3, 4 or 6 infection. The EMA will initiate review of the MAA under accelerated assessment timelines.

The MAA for grazoprevir/elbasvir (100mg/50mg) is based in part upon data from the pivotal C-EDGE clinical trials programme, as well as the C-SURFER, C-SALVAGE and C-SWIFT clinical trials, evaluating grazoprevir/elbasvir (100mg/50mg), with or without ribavirin, in patients with chronic HCV infection. Collectively, these trials evaluated treatment regimens in multiple genotypes (GT1, 3, 4 and 6), including patient populations who were previously treated, and those with cirrhosis or certain co-morbidities (i.e. HIV co-infection, chronic kidney disease stages 4 and 5).

Comment: The company submitted a New Drug Application for grazoprevir/elbasvir (100mg/50mg) to the FDA in May 2015 for the treatment of chronic HCV GT1, 4 or 6 infection, and is submitting additional license applications in other markets by the end of 2015.