Merck's grazoprevir/elbasvir gets two Breakthrough designations
US pharma giant Merck & Co’s (NYSE: MRK) grazoprevir/elbasvir, an investigational single tablet regimen for the treatment of chronic hepatitis C virus (HCV) infection, has received two new Breakthrough Therapy designations from the US Food and Drug Administration.
These are for the treatment of patients with chronic HCV genotype 4 (GT4) infection, and for the treatment of chronic HCV genotype 1 (GT1) infection in patients with end stage renal disease on hemodialysis.
Speaking at the Annual JP Morgan Healthcare Conference earlier this year, Merck said it expects to file a New Drug Application with the FDA in the first half of 2015 for grazoprevir/elbasvir, and confirmed this timeline today.
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