The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended andexanet alfa (Ondexxya, Portola Netherlands B.V.) as an antidote for adults taking the anticoagulants apixaban (Eliquis, Bristol-Myers Squibb) or rivaroxaban, (Xarelto, Bayer/Janssen Pharmaceuticals) when reversal of their anticoagulant action is needed because of life-threatening or uncontrolled bleeding.
"Until now, there has been no specific antidote that could prevent the anticoagulant effect of apixaban or rivaroxaban once they have been given," the EMA said in a statement.
In clinical testing, andexanet alfa reversed the anticoagulant effects of apixaban and rivaroxaban within 2 minutes of administration, the EMA reports.
The US Food and Drug Administration approved andexanet alfa in May 2018, with the trade name Andexxa, under the agency's accelerated approval pathway. Access was limited, though, until January 2019 pending approval of Portola's generation 2 manufacturing process, allowing a larger commercial rollout.
The CHMP also recommended conditional approval for the agent — a regulatory mechanism to facilitate early access to medicines that fulfill an unmet medical need.
Conditional approval allows the agency to recommend a medicine for marketing in the interest of public health where the benefit of its immediate availability to patients outweighs the risk inherent, even though all the data are still not available, the agency explains.
In making their recommendation, the CHMP noted that andexanet alfa has not been investigated when direct oral factor Xa inhibitors are administered before surgery or other invasive procedures; there are insufficient clinical data to support its use in patients with severe bleeding related to direct oral anticoagulants other than apixaban and rivaroxaban; formation of blood clots has been reported following treatment with andexanet alfa; and "a confirmation of the recommended dosage is yet to be expected," the release notes.
"In light of this, the company is required to complete a number of post-authorization studies to further investigate the efficacy and safety of the medicine within specified timeframes," the EMA says.
The positive CHMP opinion will now be sent to the European Commission for a final decision.
Cite this: CHMP Backs Factor Xa Reversal Agent Andexanet (Ondexxya) - Medscape - Mar 01, 2019.