The opinion adopted by the CHMP at its February 2019 meeting is an intermediary step on Ondexxya’s path to patient access. In light of this, the company is required to complete a number of post-authorisation studies to further investigate the efficacy and safety of the medicine within specified timeframes. For example, andexanet alfa has not been investigated when direct oral fXa inhibitors are administered before surgery or other invasive procedures there are insufficient clinical data to support its use in patients with severe bleedings related to direct-oral anticoagulants other than apixaban and rivaroxaban formation of blood clots has been reported following treatment with Ondexxya and a confirmation of the recommended dosage is yet to be expected. Conditional approval allows the Agency to recommend a medicine for marketing authorisation in the interest of public health where the benefit of its immediate availability to patients outweighs the risk inherent in the fact that all the data are still not available. This is one of EU's regulatory mechanisms to facilitate early access to medicines that fulfil an unmet medical need. The CHMP recommended a conditional approval for this therapy. Ondexxya enabled the reversal of the apixaban and rivaroxaban anticoagulant effect within 2 minutes of its administration. Clinical efficacy is based upon reversal of anti-fXa-activity in healthy volunteers and interim results of study in patients with life-threatening bleeding. The effects of the therapy with Ondexxya were studied in 352 patients for safety and 167 patients for efficacy. As a result, andexanet alfa neutralises the anticoagulant effect of these inhibitors. Until now, there has been no specific antidote that could prevent the anticoagulant effect of apixaban or rivaroxaban once they have been given.Īndexanet alfa, the active substance of Ondexxya, is a recombinant protein that acts as a decoy for the direct oral FXa inhibitors apixaban and rivaroxaban in the blood. 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. 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.
This medicine is to be used as an antidote for adult patients taking the anticoagulant (clot-preventing) medicines apixaban or rivaroxaban, when reversal of their action is needed due to life-threatening or uncontrolled bleeding.Īnticoagulants are used to treat blood clots and reduce the risk of them forming in the arteries and veins, which can lead to pulmonary embolism, stroke or other organ damage.
EMA’s human medicines committee ( CHMP) has recommended granting a conditional marketing authorisation in the European Union for Ondexxya (andexanet alfa).
0 kommentar(er)
