EMA conditional okay for andexanet alfaMay 8, 2019
EMA’s human medicines committee (CHMP) has recommended for granting a conditional marketing authorisation for andexanet alfa (Ondexxya) to be used as an antidote for adult patients taking the anticoagulant medicines apixaban or rivaroxaban, when reversal of their action is needed due to life-threatening or uncontrolled bleeding.
Apixaban and rivaroxaban belong to a newer class of anticoagulants called factor Xa (FXa) inhibitors, which work by blocking the action of activated factor X, a substance in the blood that has a key role in making it clot.
However, because anticoagulants stop the blood from clotting normally, patients taking them can be at risk of serious and uncontrolled bleeding, especially in emergency situations. Until now, there has been no specific antidote that could prevent the anticoagulant effect of apixaban or rivaroxaban once they have been given.
Andexanet alfa is a recombinant protein that acts as a decoy for the direct oral FXa inhibitors apixaban and rivaroxaban in the blood. As a result, andexanet alfa neutralises the anticoagulant effect of these inhibitors
The effects of the therapy were studied in 352 patients for safety and 167 patients for efficacy. Clinical efficacy is based upon reversal of anti-fXa-activity in healthy volunteers and interim results of study in patients with life-threatening bleeding.
Ondexxya enabled the reversal of the apixaban and rivaroxaban anticoagulant effect within 2 minutes of its administration.