|View printer-friendly version|
|European CHMP Adopts Positive Opinion on Ondexxya™ (andexanet alfa) Portola Pharmaceuticals’ Factor Xa Inhibitor Reversal Agent|
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
"Today's positive CHMP opinion represents a significant step forward in patient care and in the ability of clinicians to address life-threatening bleeds associated with the use of Factor Xa inhibitors," said
The MAA submission is based on data from two Phase 3 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
“Today’s opinion is an important milestone for Portola and for patients in
For a conditional approval, Portola is required to provide final study reports for both the ANNEXA-4 trial and the randomized controlled clinical trial requested by the
Andexanet alfa was approved by the FDA in May 2018 and is marketed by Portola in the U.S. under the trade name Andexxa® [coagulation factor Xa (recombinant), inactivated-zhzo].