FDA Clears Andexanet Alfa for Rapid NOAC Reversal

The FDA granted approval to Portola Pharmaceuticals' andexanet alfa (Andexxa), the first antidote indicated for patients treated with Factor Xa inhibitors rivaroxaban (Xarelto) and apixaban (Eliquis), according to a statement from the company.

Andexanet alfa is indicated for the rapid reversal of anticoagulation due to major bleeding. ANNEXA-4 investigators had reported massive reductions in anti-Factor Xa activity among rivaroxaban and apixaban recipients within hours of andexanet administration.

Portola plans a limited launch in early June, with a broader commercial launch coming in early 2019 when the FDA is expected to approve an updated manufacturing process. The agency didn't clear the reversal agent in its first try in 2016, asking for additional information related to manufacturing instead.

In 2016, there were 117,000 hospital admissions due to Factor Xa inhibitor-related bleeding and almost 2,000 bleeding-related deaths per month, Portola noted.

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