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.
“This submission to the FDA is an important milestone as we seek to provide patients with a new treatment option for this serious infection,” stated Roy Baynes, senior vice president of clinical development for Merck Research Laboratories.
Within 2 months, the FDA will determine whether it will accept the New Drug Application for review.
In addition to multiple HCV genotypes, the regimen is being researched in advanced chronic kidney disease, inherited blood disorders, and liver cirrhosis.