Portola submits MMA to EMA for IndexXa

Portola Pharmaceuticals Inc. recently announced it has submitted a Marketing Authorization Application (MAA) for IndexXa to the European Medicines Agency, noting that the validation period has been completed and it has been accepted for review.

IndexXA, a Factor Xa inhibitor antidote, was developed for the treatment of patients with a Factor Xa inhibitor when anticoagulation needs to be reversed because of life-threatening or uncontrolled bleeding. It is also meant to treat patients who require vital or emergency surgery. Portola is hoping to receive conditional approval for IndexXa in the European Union (EU).

“An estimated 73,000 patients treated with an oral Factor Xa inhibitor will be hospitalized this year due to major bleeding or because they require urgent surgery in France, Germany, Italy, Spain and the United Kingdom," Portola CEO Bill Lis said. "These patients are critically ill and could potentially benefit from a Factor Xa inhibitor antidote. As there is currently no approved antidote for Factor Xa inhibitors in the EU, we are working diligently to bring IndexXa to patients. The MAA validation is an important milestone toward achieving that goal.”

Now that the EMA’s Committee for Medical Products for Human Use (CHMP) has accepted Portola’s application for review, the centralized review procedure will commence under a standard review period of 210 days.