FDA Grants Priority Review: Once-Daily, Single-Tablet Combination for HCV
August 3, 2015
Merck’s Hepatitis C Combination Candidate Receives Priority Review
The FDA has granted priority review to Merck’s chronic hepatitis C virus (HCV) treatment candidate grazoprevir/elbasvir.
This once-daily, single-tablet combination was previously granted 2 breakthrough therapy designations for the treatment of chronic HCV genotype (GT) 4 infection, as well as chronic HCV GT1 infection in end-stage renal disease patients on hemodialysis. Now, the FDA is expected to act on grazoprevir/elbasvir 100 mg/50 mg for the treatment of adult patients infected with chronic HCV GT1, 4 or 6, on January 28, 2016.
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