Portola Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has approved its antidote for anticoagulation, Andexxa, the first drug of its kind.

The treatment is intended for patients treated with anticoagulant drugs rivaroxaban or apixaban who require a reversal of anticoagulation due to uncontrollable or life-threatening bleeding. It was approved under the FDA’s Accelerated Approval pathway, and has received both US Orphan Drug and FDA breakthrough therapy designations.

Andexxa has not been shown to be effective for the treatment of bleeding related to any FXa inhibitors other than apixaban and rivaroxaban.

Interim data from the ongoing Annexa-4 study were included in the FDA’s approval review. In the trial, Andexxa was shown to reverse anti-Factor Xa activity when administered as a bolus in 185 evaluable patients with severe bleeding. This change was sustained when followed by a 120-minute infusion. The median decrease from baseline was 90% for rivaroxaban and 93% for apixaban.

“Today’s approval represents a significant step forward in patient care and one that the medical community has been eagerly anticipating,” Annexa-4 executive committee chairman Stuart J. Connolly said.

“Andexxa’s rapid reversal of the anticoagulating effects of rivaroxaban and apixaban will help clinicians treat life-threatening bleeds, where every minute counts.”

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The approval also follows data from two Phase III trials of Andexxa, the results of which were published in The New England Journal of Medicine in September 2016. The studies examined the safety and efficacy of Andexxa in reversing the anticoagulant activity of Factor Xa inhibitors rivaroxaban and apixaban in healthy volunteers. In both trials, the treatment was shown to significantly reverse anti-Factor Xa activity, with a median decrease in anti-Factor Xa activity from baseline at 97% for rivaroxaban and 92% for apixaban.

Factor Xa inhibitors have been growing increasingly popular due to their efficacy and safety profile when treating thromboembolic conditions such as stroke, pulmonary embolism and venous thromboembolism (VTE). This increase has, however, come with a correlated increase in cases of bleeding-related hospital admissions and deaths. In the US, there were around 117,000 hospital admissions attributable to Factor Xa inhibitor-related bleeding in 2016, and nearly 2,000 bleeding-related deaths per month of that year.

“We are grateful to the patients who participated in our trials, our clinical trial collaborators, our employees and the FDA for their help in bringing this new drug to market for the benefit of patients with Factor Xa inhibitor-related bleeding,” Portola CEO Bill Lis said.

“We are proud that Andexxa is a first-in-class medicine discovered in our labs. In addition to Bevyxxa, the first and only anticoagulant approved for extended VTE prevention in acute hospitalised medical patients, Andexxa is our second FDA-approved product with the potential to save lives and have a major impact on global public health. We remain committed to our scientific leadership in the fields of thrombosis and haematologic cancers.”

The post-marketing requirement is a clinical trial that randomises patients to receive either Andexxa or usual care. This study is scheduled to be initiated in 2019, with findings presented in 2023.