The U.S. Food and Drug Administration will extend its review of the biologics license application for Portola Pharmaceuticals Inc.'s AndexXa by 90 days.
The regulator will now take an action on the application by May 4, 2018, instead of Feb. 3, 2018.
Portola recently submitted additional data requested by the agency for an ongoing study as part of the 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.
The company 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.
Andexanet alfa is also under review by the European Commission. A final decision by the European Commission on the marketing authorization application for andexanet alfa is anticipated in the first half of 2018.