Merck Submits New Drug Application for Hepatitis Combination

By Josh Beckerman 

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.

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