Friday, March 02, 2012

Pfizer, Bristol-Myers: FDA ruling on approval of anticlotting drug Eliquis postponed 3 months - The Washington Post

TRENTON, N.J. — Federal regulators have pushed back the deadline for deciding whether to approve a highly touted experimental anticlotting drug developed jointly by Pfizer Inc. and Bristol-Myers Squibb Co.

The companies said late Wednesday that the Food and Drug Administration has set a new target date of June 28 for deciding whether to approve Eliquis. That’s three months later than originally scheduled.

The drugmakers, both based in New York, said that after submitting their original application for approval of the drug, they sent the FDA additional information from patient studies. The new information will require more time for review.

Eliquis, known chemically as apixaban, is one of three new drugs meant to prevent heart attacks and strokes better than the longtime standard treatment, warfarin. The other two are already approved in the U.S. All three could become blockbusters, bringing their makers much-needed new revenue.

Posted via email from Jack's posterous

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