Merck’s Chances Are Good for an FDA Approval
June 3, 2015
Merck submits NDA for new 2-in-1 hepatitis C treatment
By Nicole Gray
- 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.
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