The U.S. Food and Drug Administration has approved andexanet alfa (Andexxa), according to the drug’s manufacturer, Portola Pharmaceuticals Inc.
The drug had received both orphan drug and breakthrough therapy designations and was initially approved on May 3, 2018, under the FDA's accelerated approval pathway. It is the first and only antidote indicated for patients treated with rivaroxaban (Xarelto, Janssen Pharmaceuticals) or apixaban (Eliquis, Bristol-Myers Squibb Co.), when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding, according to Portola’s news release.
“It is clear from the response to the Andexxa Early Supply Program that there is significant need for a specific reversal agent that can address life-threatening bleeding associated with the use of the Factor Xa inhibitors apixaban and rivaroxaban,” said Scott Garland, Portola’s president and CEO, in the release, issued Monday, Dec. 31, 2018. “We are pleased to now be able to stock hospitals nationwide and serve all patients in the U.S. who could benefit from the potential life-saving impact of Andexxa.”
Portola said it will release more details during its annual corporate webcast, scheduled for 10 a.m. EST Tuesday, Jan. 8, 2019, at www.portola.com. The company added that it plans a full commercial launch in January 2019.