FDA Approval of Andexxa Marks Historic Decision

First approval reversal agent for factor Xa inhibitors

The United States Food and Drug Administration (FDA) has approved Andexxa (coagulation factor Xa [recombinant] inactivated-zhzo) to reverse the anticoagulation effects of factor Xa inhibitors when needed due to life-threatening or uncontrolled bleeding, Portola Pharmaceuticals has announced.

An estimated 4 million people are taking factor Xa inhibitors, such as rivaroxaban (Xarelto, Bayer/Janssen Pharmaceuticals) and apixaban (Eliquis, Bristol-Myers Squibb), but until now, there has been no approved reversal agent.

Last month, the FDA gave full approval to idarucizumab (Praxbind, Boehringer Ingelheim) to reverse the anticoagulant effect of dabigatran (Pradaxa, Boehringer Ingelheim), a direct thrombin inhibitor, in the event of urgent surgery or life-threatening or uncontrolled bleeding.

In the United States alone, there were approximately 117,000 hospital admissions attributable to factor Xa inhibitor-related bleeding and nearly 2000 bleeding related deaths per month, according to the company’s news release, posted May 3.

“The expansion of available reversal agents for people prescribed newer oral anticoagulant therapies is crucial,” Randy Fenninger, chief executive officer of the National Blood Clot Alliance, said in the release. “The availability now of a reversal agent specific to rivaroxaban and apixaban expands choice and enables patients and providers to consider these treatment options with greater confidence.”

SOURCE: Medscape

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