Merck & Co. has submitted a New Drug Application to the U.S.
Food and Drug Administration for an experimental drug combination
for treating certain chronic hepatitis C patients.
The company said it plans to submit applications for Europe and
other markets for the combination of grazoprevir and elbasvir by
the end of the year.
Within 60 days, the FDA will determine whether it will accept
the application for review as filed.
Merck said in April that the combination for treating chronic
hepatitis C patients demonstrated a 95% effective rate in a
late-stage study.
The combined tablet poses a potential threat to hepatitis market
leader Gilead Sciences Inc., which analysts estimate raked in at
least $12 billion in combined sales in 2014 from the blockbuster
drug Sovaldi and the first all-oral combination drug, Harvoni.
Another competitor is AbbVie Inc., which recently launched its
Viekira Pak.
As patent expirations weigh on drug makers, Kenilworth,
N.J.-based Merck has been overhauling its research-and-development
engine in hopes of introducing new treatments at least several
months earlier than expected.
Write to Josh Beckerman at josh.beckerman@wsj.com
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