Posted by Michael Wonder on 22 Aug 2016
Portola Pharmaceuticals announces validation of marketing authorization application by European Medicines Agency for IndexXa (andexanet alfa), a factor Xa inhibitor antidote
19 August 2016 - Portola Pharmaceuticals today 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.
