This article is a collaboration between 乌鸦传媒 and:
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.
![author['full_name']](https://clf1.medpagetoday.com/media/images/author/nicoleLou_188.jpg)