FDA approves first factor Xa inhibitor antidote

The first-and-only antidote indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding, will begin a limited rollout in June.

Coagulation factor Xa (recombinant), inactivated-zhzo (Andexxa, Portola Pharmaceuticals), which FDA approved in early May, costs $27,500 per gram, which approximates the average per patient dose.

“The price of Andexxa reflects its novel attributes, as well as its Orphan Drug Designation and the targeted population of high-risk patients that will benefit from the use of Andexxa,” a Portola spokesperson told FormularyWatch.

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Portola expects to launch Andexxa in early June to a limited number of hospitals (30 to 40) that are predominantly ANNEXA-4 clinical trial sites, along with a limited number of level 1 trauma centers and comprehensive stroke centers.

“This limited launch will allow us to leverage the relationships and experience of our clinical trial sites to reach some of the highest-risk patients, and importantly, to serve as a bridge for the Generation 2 drug supply,” the spokesperson said. “We’re anticipating a broader commercial launch in early 2019 upon FDA approval of the Generation 2 manufacturing process for Andexxa.”

Andexxa received both U.S. Orphan Drug and FDA Breakthrough Therapy designations and was approved under FDA’s Accelerated Approval pathway based on the change from baseline in anti-factor Xa activity in healthy volunteers. Continued approval for this indication may be contingent upon post-marketing study results to demonstrate an improvement in hemostasis in patients.

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“Today’s approval represents a significant step forward in patient care and one that the medical community has been eagerly anticipating,” said Stuart J. Connolly, MD, ANNEXA-4 Executive Committee chairman and professor in the department of medicine of the Faculty of Health Sciences at McMaster University in Hamilton, Ontario, Canada, in a Portola statement.“Andexxa’s rapid reversal of the anticoagulating effects of rivaroxaban and apixaban will help  clinicians treat life-threatening bleeds, where every minute counts.”

The unmet medical need and the number of patients admitted to the hospital with Factor Xa-inhibitor-related bleeding is significant and continues to grow, according to Portola. In 2016, there were approximately 117,000 hospital admissions in the United States. and nearly 2,000 deaths attributable to factor Xa inhibitor-related bleeding.

“Patients with the most severe life-threatening bleeds have 30-day mortality rates of up to 40%, with an average hospital stay of 10 days or more, and the cost to manage these patients in the hospital exceeds $100,000,” the Portola spokesperson said.

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