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The FDA granted approval to Portola Pharmaceuticals' andexanet alfa (Andexxa), the first antidote indicated for patients treated with Factor Xa inhibitors rivaroxaban (Xarelto) and apixaban (Eliquis), according to a from the company.
Andexanet alfa is indicated for the rapid reversal of anticoagulation due to major bleeding. ANNEXA-4 investigators had reported massive reductions in anti-Factor Xa activity among rivaroxaban and apixaban recipients within hours of andexanet administration.
Portola plans a limited launch in early June, with a broader commercial launch coming in early 2019 when the FDA is expected to approve an updated manufacturing process. The agency didn't clear the reversal agent in its first try , asking for additional information related to manufacturing instead.
In 2016, there were 117,000 hospital admissions due to Factor Xa inhibitor-related bleeding and almost 2,000 bleeding-related deaths per month, Portola noted.
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