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   news News of medicine. 2013 | Archive
 
 

Apixaban Wins Long-Awaited Nod from FDA

 
 

04/02/2013
The FDA has approved the oral anticoagulant drug apixaban (Eliquis) to prevent stroke and systemic embolism in patients with nonvalvular atrial fibrillation, the agency announced late Friday.

The approval follows similar decisions by regulators in Europe, Canada, and Japan, which also cleared the oral Factor Xa inhibitor for this indication in recent weeks.

Apixaban's safety and efficacy for the afib indication in the U.S. were evaluated in a clinical trial involving more than 18,000 patients that compared the drug with warfarin, the FDA said in a statement. In the trial, patients taking apixaban had fewer strokes than those who took warfarin.

However, in another trial, apixaban failed to show a benefit relative to a different comparator, enoxaparin (Lovenox). Concerns were also raised about possibly increased bleeding risks, although these have not been seen consistently.

In June, the FDA said it was delaying a decision until the drug's sponsors, Bristol-Myers Squibb and Pfizer, submitted additional data related to the pivotal ARISTOTLE trial. In announcing the approval, the FDA said the drug is contraindicated in patients with prosthetic heart valves.

The agency also noted that there is currently no antidote to reverse the drug's anticoagulant effect should severe bleeding occur. Apixaban will come with a patient medication guide that provides instructions on its use and drug safety information, the FDA said.

"Healthcare professionals should counsel patients on signs and symptoms of possible bleeding," the agency added.

 
   
 

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