Portola Pharmaceuticals Provides Update on Biologics License Application (BLA) for AndexXa® (andexanet alfa)

go site SOUTH SAN FRANCISCO, Calif., Dec. 22, 2017 (GLOBE NEWSWIRE) — Portola Pharmaceuticals, Inc.® (Nasdaq:PTLA) today announced that the U.S. Food and Drug Administration (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 today, the FDA communicated that the action date will move from February 3, 2018 to May 4, 2018.