Posted by Michael Wonder on 04 Mar 2019
European CHMP adopts positive opinion on Ondexxya (andexanet alfa) Portola Pharmaceuticals’ factor Xa inhibitor reversal agent
1 March 2019 - Portola Pharmaceuticals today announced that the CHMP of the 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.
