Pfizer, Bristol-Myers to Get March FDA Ruling on Eliquis Drug

Pfizer Inc. (PFE), the world’s largest drugmaker, and Bristol-Myers Squibb Co. (BMY) may have to wait until March for word on whether their experimental blood thinner Eliquis passes U.S. regulatory scrutiny.

The pill was rejected by the Food and Drug Administration in June after the agency said it needed more information from the companies’ existing trials. The two New York-based companies said in a statement today they had given the FDA all the data requested and were assigned a target decision date of March 17.

Revenue from Eliquis has the potential to peak at $4.7 billion if approved, Catherine Arnold, an analyst with Credit Suisse Group AG in New York, estimated in a note this month. The pill, which could replace the drug Warfarin as the standard of care, would also help make up for sales that the companies have lost from their own top-selling blockbusters.

Pfizer’s Lipitor and Bristol-Myers’s Plavix lost patent protection within the past 12 months and now face generic competition.

Johnson & Johnson (JNJ), based in New Brunswick, New Jersey, and Leverkusen, Germany-based Bayer AG (BAYN) have a competing pill Xarelto, as does Boehringer Ingelheim GmbH, of Ingelheim, Germany.

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