FDA Accepts Grazoprevir/Elbasvir NDA for Chronic HCV

Merck announced that the Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for grazoprevir/elbasvir (Zepatier; Merck) 100mg/50mg for the treatment of adult patients infected with chronic hepatitis C virus (HCV) genotypes (GT) 1, 4, or 6.

The NDA for grazoprevir/elbasvir is based on data from the C-EDGE clinical trials program, as well as the C-SURFER and C-SALVAGE trials. Collectively, these trials evaluated treatment regimens of grazoprevir/elbasvir, with or without ribavirin, in multiple genotypes (GT1, 4, and 6) including patient populations who were previously treated, and those with cirrhosis or certain co-morbidities (eg, HIV/HCV co-infection, advanced chronic kidney disease, inherited blood disorders).

RELATED: First All-Oral Therapy for Genotype 4 HCV Approved

In April 2015, the FDA granted Breakthrough Therapy designation status for grazoprevir/elbasvir for the treatment of patients infected with chronic HCV GT1 with end stage renal disease on hemodialysis and for the treatment of patients infected with chronic HCV GT4. The FDA granted Priority Review for grazoprevir/elbasvir, with a Prescription Drug User Fee Act (PDUFA) action date of January 28, 2016.

Grazoprevir/elbasvir (100mg/50mg) is a once-daily, single-tablet combination therapy consisting of grazoprevir (HCV NS3/4A protease inhibitor) and elbasvir (HCV NS5A replication complex inhibitor).

For more information call (800) 672–6372 or visit Merck.com.

Loading links....