Conditional approval for Ondexxya for the reversal of the anticoagulant effects of Factor Xa inhibitors

Portola Pharmaceuticals, Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion on the marketing authorization application (MAA) for Ondexxya (andexanet alfa). The Committee has recommended that the European Commission (EC) grant Ondexxya conditional approval for the reversal of the anticoagulant effects of the Factor Xa inhibitors apixaban or rivaroxaban in patients experiencing uncontrolled or life-threatening bleeding.

The MAA will now be reviewed by the EC, which has the authority to approve medicines for use in the 28 countries of the European Union, Norway, Liechtenstein and Iceland. If approved, Ondexxya would be the first and only specific reversal agent available in Europe to address life-threatening bleeding associated with the use of apixaban or rivaroxaban. The EC is expected to issue a decision in early May 2019.

The MAA submission is based on data from two Phase III ANNEXA studies that evaluated the safety and efficacy of Ondexxya in reversing the anticoagulant activity of the Factor Xa inhibitors rivaroxaban or apixaban in healthy subjects. Results of the ANNEXA studies were published in 2015 in The New England Journal of Medicine. The MAA also included adjudicated efficacy and safety data from bleeding patients enrolled in ANNEXA-4, the Company’s Phase IIIb/IV study, the full results of which were published in The New England Journal of Medicine in February 2019.