Merck announced that it has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for grazoprevir/elbasvir (Zepatier; Merck) 100mg/50mg for the treatment of adults with chronic hepatitis C genotypes 1, 4, or 6 infection.

The NDA submission for grazoprevir/elbasvir is based in part upon data from the C-EDGE clinical trials program, as well as the C-SURFER and C-SALVAGE trials, evaluating grazoprevir/elbasvir, with or without ribavirin, in patients with chronic hepatitis C infection.

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Grazoprevir/elbasvir is an investigational, once-daily single tablet regimen consisting of grazoprevir, a NS3/4A protease inhibitor and elbasvir, a NS5A replication complex inhibitor. As part of Merck’s clinical trials program, grazoprevir/elbasvir is being studied in multiple HCV genotypes and in patients with difficult-to-treat conditions such as HIV/HCV co-infection, advanced chronic kidney disease, inherited blood disorders, cirrhosis and those on opiate substitution therapy.

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