Andexanet alfa regulatory update

FDA issued a complete response letter to Portola for a BLA for AndexXa andexanet alfa to reverse the anticoagulant activity of direct and indirect Factor Xa inhibitors. On a conference call to discuss the letter, the company said the letter’s “dominant portion” outlined FDA’s concerns about manufacturing of the reverse anticoagulant. Portola noted that the agency conducted a pre-approval inspection in April that identified “very few, if any non-critical” issues. The agency is requesting more information about Portola’s specifications and assays, issues that the company believed could be addressed after approval.

Portola also said FDA requested additional data to support the inclusion on AndexXa’s label of the marketed Factor Xa inhibitors Lixiana edoxaban and enoxaparin. Portola is seeking AndexXa’s approval to reverse the activity of any of 4 anticoagulants, including those 2, in the event of a life-threatening or uncontrolled bleeding episode. The company said FDA requested data on bolus dosing of AndexXa in healthy volunteers. Additionally, FDA asked Portola to finalize its review of clinical amendments to its postmarketing commitments, the company said. Portola plans to meet with FDA as soon as possible. The company said it could resubmit the BLA for AndexXa by year end. ...