Portola Pharma (PTLA) Receives CRL from FDA for Andexanet Alfa

August 18, 2016 6:16 AM EDT

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Portola Pharmaceuticals Inc. (Nasdaq: PTLA) announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for AndexXa™ (andexanet alfa). An FDA-designated Breakthrough Therapy, AndexXa is in development for patients treated with a direct (apixaban, rivaroxaban, or edoxaban) or indirect (enoxaparin) Factor Xa inhibitor when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. Currently, there is no FDA-approved antidote for Factor Xa inhibitors.

In the CRL for AndexXa, the FDA requested that Portola provide additional information primarily related to manufacturing. The agency also asked for additional data to support inclusion of edoxaban and enoxaparin in the label, and indicated it needs to finalize its review of the clinical amendments to Portola’s post-marketing commitments that recently were submitted.

“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’s goal is to define the most expedient path to approval so we can meet the needs of these patients who have no alternative,” said Bill Lis, chief executive officer of Portola. “We plan to meet with the FDA as soon as possible.”

Conference Call Details The Portola management team will host a conference call and webcast tomorrow, Thursday, August 18, 2016, at 8:30 am ET to provide more information about AndexXa. The live call can be accessed by phone by calling 1 (844) 452-6828 (domestic) or 1 (765) 507-2588 (international) and specifying conference call code 68482562. The webcast can be accessed live on the Investor Relations section of the Company's website at http://investors.portola.com. It will be archived for 30 days following the call.

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