FDA extends PDUFA date for AndexXa for reversal of coagulation.- Portola Pharma

Portola Pharmaceuticals, Inc. announced that the FDA will extend its review of the Biologics License Application (BLA) for AndexXa (andexanet alfa) by 90 days. The company recently submitted additional data requested by the agency for the ongoing ANNEXA-4 study as part of the continuing review process, which constitutes an amendment to the submission. Therefore, the agency has instituted an extension to allow more time for a thorough review of the information provided and to work with the company on labeling and post-marketing commitments.

In correspondence dated and issued 22 December 2017, the FDA communicated that the action date will move from February 3, 2018 to May 4, 2018. Portola is developing AndexXa 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 BLA seeks initial approval of AndexXa for reversal of the anticoagulant effects of apixaban and rivaroxaban in patients experiencing uncontrolled or life-threatening bleeding.

Major bleeding (e.g., intracranial hemorrhage, gastrointestinal bleeding and bleeding into other critical organs) in patients taking Factor Xa inhibitor anticoagulants has become a significant cause of hospital admissions, morbidity and patient mortality. In 2016, approximately 90,000 patients in the U.S. treated with oral Factor Xa inhibitors were subsequently admitted to the hospital due to bleeding. Including patients taking the injectable Factor Xa inhibitor enoxaparin, it is estimated that more than 150,000 U.S. patients could benefit from an antidote annually. Andexanet alfa is also under review by the European Commission of the European Medicines Agency (EMA). A final decision by the European Commission on the marketing authorization application (MAA) for andexanet alfa is anticipated in the first half of 2018.