FDA Delays BLA for Bleeding Antidote to Anticoagulants

The U.S. Food and Drug Administration (FDA) moved the action date for the biologics license application (BLA) of andexanet alfa, a bleeding antidote for blood thinners, from February 3, 2018, to May 4, 2018. The 90-day review period extension will allow the FDA to consider additional information from the ongoing ANNEXA-4 study.

Portola Pharmaceuticals is developing andexanet alfa 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 need emergency surgery.

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 Commission of 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 press release, December 22, 2017.