Update on CHMP review of andexanet alfa for reversal of anticoagulation. - Portola Pharma.
Portola Pharmaceuticals, Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has communicated a positive trend vote on the Marketing Authorisation Application (MAA) for andexanet alfa, a Factor Xa-inhibitor reversal agent. Portola is seeking conditional approval for andexanet alfa for the reversal of the anticoagulant effects of the Factor Xa inhibitors apixaban and rivaroxaban in patients experiencing uncontrolled or life-threatening bleeding. Andexanet alfa is also currently under review by the FDA with an anticipated action date of 4 May 2018. New interim data from the Company�s ongoing Phase IIIb/IV trial of andexanet alfa (ANNEXA-4) will be presented on Monday, March 12, 2018 during a Late-Breaking Clinical Trial Session at the American College of Cardiology�s 67th Annual Scientific Session & Expo (ACC.18)
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
1 mins