Portola's Ondexxya conditionally cleared in Europe as antidote for reversal of Factor Xa inhibitors

Portola Pharmaceuticals on Friday said that the European Commission has granted conditional approval to Ondexxya (andexanet alfa) for use in adults requiring reversal of anticoagulation due to life-threatening or uncontrolled bleeding following treatment with Bristol-Myers Squibb and Pfizer's Eliquis (apixaban) or Bayer and Johnson & Johnson's Xarelto (rivaroxaban). The drugmaker noted that Ondexxya will be the first treatment for reversing the effects of Factor Xa inhibitors approved in Europe. Portola CEO Scott Garland remarked "the unmet need for a reversal agent in Europe is significant, as the number of patients taking a Factor Xa inhibitor is nearly double that of the US and continuing to grow at a significant rate."

The European conditional approval of the drug was backed by efficacy and safety data from the Phase III ANNEXA-R and ANNEXA-A studies as well as results from the Phase IIIb/IV ANNEXA-4 trial. In study findings unveiled in 2015, Ondexxya was found to significantly reverse anti-Factor Xa activity in healthy volunteers. Meanwhile, full results from the ANNEXA-4 trial released in February illustrated the efficacy of the therapy, which is marketed in the US under the name Andexxa, in patients experiencing acute major bleeding during treatment with a Factor Xa inhibitor.

The decision comes after the European Medicines Agency's Committee for Medicinal Products for Human Use extended its review of the drug last December. For related analysis, see ViewPoints: No port in a storm for Portola as it faces new regulatory delays.

The treatment was authorised last May for the same indication in the US, with sales of the drug reaching $14 million in the fourth quarter of 2018.

For additional analysis, see also ViewPoints: Portola starts crucial year off on the right foot.

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