FDA Delays BLA Review for Andexanet Alfa as Anticoagulation Reversal Agent

The FDA extended by 90 days its review of the biologics license application (BLA) for andexanet alfa for the second time, from February 3 to May 4, 2018. The drug’s manufacturer, Portola Pharmaceuticals, Inc., recently submitted additional data requested by the FDA for the ongoing ANNEXA-4 study, and the agency moved the action date to evaluate the new information.

Andexanet alfa is intended as a universal reversal agent for patients anticoagulated with an oral or injectable factor Xa inhibitor who experience a serious uncontrolled or life-threatening bleeding event or who require urgent or emergency surgery. The initial BLA is seeking approval for andexanet as a reversal agent for the anticoagulant effects of apixaban and rivaroxaban.

The company had first hoped to get approval of its agent in August 2016, but the FDA issued a complete response letter seeking more information about Portola’s manufacturing, as well as additional data for inclusion of two other anticoagulants in the label, edoxaban and enoxaparin.

Andexanet alfa also is under review by the European Medicines Agency. A final decision by the European Commission on the marketing authorization application is anticipated in the first half of 2018.

Source: Portola Pharmaceuticals, Inc., news release, December 22, 2017.