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UPDATE 1-FDA to decide by March on Pfizer/Bristol blood thinner
September 26, 2012 / 9:50 PM / 5 years ago

UPDATE 1-FDA to decide by March on Pfizer/Bristol blood thinner

* FDA asked for more information on drug in June

* Eliquis also awaiting European approval decision

* Seen as important drug in market for new blood clot preventers

Sept 26 (Reuters) - U.S. health regulators set a date of March 17 to decide whether to approve a closely watched blood clot preventer developed by Bristol-Myers Squibb Co and Pfizer Inc for use in patients with atrial fibrillation, the companies said on Wednesday.

The U.S. Food and Drug Administration in June declined to approve the drug, Eliquis, and asked the companies to provide more information on a pivotal clinical trial of the medicine, which is designed to reduce the risk of stroke caused by blood clots in heart patients.

Wall Street and the medical community widely expect approval of Eliquis, known chemically as apixaban, and see it becoming a major player in an estimated $10 billion market for new alternatives to the decades old blood thinner warfarin.

Atrial fibrillation, a common form of dangerously irregular heartbeat, is seen as by far the largest and most important use for the new blood clot preventers. Some 12 million people in the United States and Europe have the condition, which puts them at high risk of suffering a stroke.

Eliquis is also awaiting an approval decision in Europe, where a committee of experts for European regulators last week recommended its approval.

The drug proved to be more effective in clinical trials than warfarin, which must be closely monitored to prevent dangerous bleeding.

If approved, Eliquis will compete with Xarelto from Bayer and Johnson & Johnson and Boehringer Ingelheim’s Pradaxa.

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