Merck's Hepatitis C Combination Candidate Receives Priority Review
The FDA has granted priority review to Merck's chronic hepatitis C virus (HCV) treatment candidate grazoprevir/elbasvir.
The FDA has granted priority review to Merck’s chronic hepatitis C virus (HCV) treatment candidate grazoprevir/elbasvir.
This once-daily, single-tablet combination was previously granted 2 breakthrough therapy designations for the treatment of chronic HCV genotype (GT) 4 infection, as well as chronic HCV GT1 infection in end-stage renal disease patients on hemodialysis.
Now, the FDA is expected to act on grazoprevir/elbasvir 100 mg/50 mg for the treatment of adult patients infected with chronic HCV GT1, 4 or 6, on January 28, 2016.
“The FDA’s Priority Review designation for grazoprevir/elbasvir underscores how innovative treatment approaches for chronic hepatitis C are still needed for many patient populations,” stated Roy Baynes, senior vice president of clinical development at Merck Research Laboratories. “…We look forward to continuing our dialogue with the FDA to bring this novel combination medicine to the appropriate patients with chronic hepatitis C.”
The New Drug Application for grazoprevir/elbasvir is partially based on encouraging data from the C-EDGE, C-SURFER, C-SALVAGE clinical trials program, which evaluated the treatment with or without ribavirin in HCV GT1, 4 and 6, including patients who were previously treated, as well as those with cirrhosis or certain co-morbidities.
In addition to being studied in multiple chronic HCV genotypes and HIV co-infection, grazoprevir/elbasvir is undergoing clinical trials in chronic kidney disease, inherited blood disorders, and cirrhosis, as well as subjects taking opiate substitution therapy.
The most common side effects associated with the drug in clinical trials include fatigue, headache, nausea, and diarrhea.