FDA approves new use for Bristol-Myers/Pfizer’ Eliquis

16 March 2014
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The US Food and Drug Administration has approved pharma major Bristol-Myers Squibb’s (NYSE: BMY) supplemental New Drug Application for blood thinner Eliquis (apixaban) for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery.

Eliquis is currently sold in partnership with drugs behemoth Pfizer (NYSE: PFE) to prevent blood clots that can cause strokes in patients with atrial fibrillation, an irregular heartbeat that is most common in the elderly. Of the new oral anticoagulants, only German drug major Bayer’s (BAYN: DE) Xarelto (rivaroxaban), marketed with Johnson & Johnson, had been previously approved for DVT prophylaxis in orthopedic patients.

“Today’s FDA approval of Eliquis for DVT prophylaxis in patients who have undergone hip or knee replacement is a significant milestone for this important medicine, which is also approved to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation,” said Brian Daniels, senior vice president, global development and medical affairs, at Bristol-Myers Squibb.

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