Portola receives CRL from FDA for AndexXa BLA

Portola Pharmaceuticals Inc. recently received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the Biologics License Application (BLA) submitted for AndexXa (andexanet alfa).

AndexXa, which has already been granted Breakthrough Therapy designation from the FDA, is being developed to treat patients with direct or indirect Factor Xa inhibitor in cases where anticoagulation needs to be reversed because of bleeding that is life-threatening or uncontrollable. There are no current antidotes for Factor Xa inhibitors approved by the FDA.

“Because AndexXa addresses an urgent unmet medical need, we and the FDA are committed to resolving the outstanding questions and determining appropriate next steps,” Portola CEO Bill Lis said. “Portola’s goal is to define the most expedient path to approval so we can meet the needs of these patients who have no alternative. We plan to meet with the FDA as soon as possible.”

The FDA requested that Portola provide additional manufacturing information on AndexXa in its CRL to the company. Also included in the CRL was the request for more data to justify including edoxaban and enoxaparin on the label. The FDA also stated that it must finalize its review of the clinical amendments to the post-marketing commitments.