FDA to rule on Bristol-Myers/Pfizer drug in March

AP News
Posted: Sep 26, 2012 6:17 PM
FDA to rule on Bristol-Myers/Pfizer drug in March

NEW YORK (AP) — Bristol-Myers Squibb Co. and Pfizer Inc. said Wednesday the Food and Drug Administration has accepted a new application for their anti-clotting drug Eliquis and will make a decision by March 17.

The companies want the FDA to allow them to market Eliquis as a preventive treatment for stroke and embolism in patients with atrial fibrillation, a type of irregular heartbeat. The FDA has twice delayed approval of Eliquis.

Eliquis is one of three drugs in a new class of blood thinners seen as big moneymakers. The other two drugs are Boehringer Ingelheim's Pradaxa, which was approved by the FDA in late 2010, and Bayer HealthCare and Johnson & Johnson's Xarelto, which was approved in November 2011.

The FDA was scheduled to make a decision on Eliquis in March 2011 before saying it needed more time to review additional data the companies had submitted. In June the FDA asked for more information from large international studies of the drug.

European Union regulators approved the drug in May 2011 for preventing blood clots in patients having hip or knee replacement surgery, a smaller pool of patients than those with atrial fibrillation. Earlier this month a European Union regulatory panel recommended that Eliquis be approved for preventing strokes in atrial fibrillation patients.

Bristol-Myers Squibb shares fell 31 cents to $33.66 during regular trading, and shed another 4 cents to $33.62 in after-hours trading. Shares of Pfizer lost a penny to $24.83 during the day and added 5 cents to $24.88 in the late session.