IndexXa (andexanet alfa) MAA is submitted to EMA for reversal of anticoagulation.- Portola Pharma

Portola Pharmaceuticals Inc.announced that the MAA for IndexXa (andexanet alfa; trade name in the United States is AndexXa), a Factor Xa inhibitor antidote, has been submitted to the EMA, completed the validation period, and has been accepted for review. IndexXa is in development for patients treated with a Factor Xa inhibitor when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding and for patients requiring urgent or emergency surgery. Portola is seeking conditional approval of IndexXa in the EU through the centralized procedure. With the acceptance of the application, the EMA�s Committee for Medicinal Products for Human Use (CHMP) will now begin the centralized review procedure under a standard 210-day review period.

Comment: Yesterday the FDA issued a Complete Response Letter for AndexXa ( US name of the drug), requesting 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.