Tuesday, June 2, 2015

Merck Drug Seeks FDA Approval for 3 Hepatitis C Genotypes

Merck is seeking FDA approval for its once-daily, single-tablet grazoprevir/elbasvir combination for the treatment of adult patients with chronic hepatitis C virus (HCV) genotypes 1, 4, or 6 infection.

Grazoprevir 100 mg/elbasvir 50 mg previously received Breakthrough Therapy designation from the FDA for the treatment of patients with chronic HCV genotype 1 with end-stage renal disease on hemodialysis, as well as patients infected with chronic HCV genotype 4.

Merck’s submission for the drug’s FDA approval is partially based on positive data from the C-EDGE trial program, as well as the C-SURFER and C-SALVAGE trials, which evaluated the investigational combination with or without ribavirin in chronic HCV patients.

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http://www.pharmacytimes.com/product-news/Merck-Drug-Seeks-FDA-Approval-for-3-Hepatitis-C-Genotypes?utm_source=GoogleNews&utm_medium=GoogleNews&utm_campaign=PharmacyTimesNews

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