- The FDA will review grazoprevir/elbagavir (100mg/50mg), an investigational single tablet regimen (STR), for treatment of hepatitis C (HCV) genotypes 1, 4 and 6.
- Previously the FDA granted breakthrough status to grazoprevir/elbagavir for treatment of patients with HCV GT1 with end-stage renal disease on hemodialysis, as well as HCV GT4.
- Merck will submit additional applications in European and other markets by the end of the year.
Merck's clinical trial program for its grazoprevir/elbagavir submission is extensive. During the recent International Liver Congress in April 2015, there were 14 individual abstracts highlighting the data from these trials. All told, the FDA has deemed grazoprevir/elbagavir as worthy of Breakthrough Designation Status, and chances are good that an approval will be forthcoming.
Although Merck's current submission for grazoprevir/elbagavir seems broad, the company has developed an even more ambitious clinical study program in which the combo drug is being tested in patients with HCV/HIV co-infection, advanced chronic kidney disease, inherited blood disorders and liver cirrhosis. It is also being tested in individuals who are being treated with opiate substitution therapy.