Portola's anticoagulant antidote MAA validated in Europe
Hot on the heels of a Food and Drug Administration set back in the approval of its anticoagulant antidote, US biotech firm Portola Pharmaceuticals (Nasdaq: PTLA) has received better news from European regulators.
On Friday, Portola announced that the marketing authorization application (MAA) for IndexXa (andexanet alfa; trade name in the USA is AndexXa), a Factor Xa inhibitor antidote, has been submitted to the European Medicines Agency, 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 European Union 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.
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