Wednesday, November 21, 2012

Bristol (BMY) – Pfizer (PFE) anticlot drug gets key EU approval

A new anti-clotting drug, Eliquis, useful in preventing strokes and dangerous clots in the circulatory system has been approved by the European Union, makers of the drug Bristol Myers Squibb Co.(NYSE:BMY) - Pfizer Inc.(NYSE:PFE ) said on Tuesday.

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The drug has been approved for use in 27 European Union countries in patients who have an irregular heartbeat called atrial fibrillation and are at risk for strokes or dangerous clots called systemic embolisms, they said.

The drug has been developed in a partnership between Pfizer and Bristol-Myers Squib and this is the second approval for the drug by European regulators.

The earlier approval was given in May 2011 for preventing dangerous clots from forming in deep veins after hip or knee replacement surgery.

The current approval means that the drug can be used for a wider range of patients. In Europe alone, about 6 million people have atrial fibrillation, the two New York-based companies noted.

However the drug has not yet been approved for sale in the United States, here it had twice been rejected by the U.S. Food & Drug Administration.

The USFDA has sought for more time to review the data submitted by the two companies involved in the development of the drug. It was supposed to have taken a decision on it by March 2012, but so far there has been no communication from the agency.

In a statement Tuesday, Pfizer and Bristol-Myers said that Eliquis is the only anticlotting drug proven to be better than warfarin at reducing risk of stroke, major bleeding and death from any cause.

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