Merck’s Chances Are Good for an FDA Approval
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The Editors at Hepatitis Central
June 3, 2015
Find out about Merck’s hepatitis drug that is also being tested for HCV/HIV co-infection, liver cirrhosis and more in a clinical trial program.
Merck submits NDA for new 2-in-1 hepatitis C treatment
By Nicole Gray
Dive Brief:
- 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.
Continue reading this entire article:
http://www.biopharmadive.com/news/merck-submits-nda-for-new-2-in-1-hepatitis-c-treatment/399932/
