In January, the FDA approved a Prior Approval Supplement for the second generation of andexanet alfa, allowing for its broad commercial launch in the U.S. The drug was approved by the FDA in May, though distribution has been limited to centers that participated in the trials. , MD, research director of Ascension Seton Dell Medical School Stroke Institute in Austin, Texas, presented the full data at the International Stroke Conference, presented full data here. Andexanet alfa reversed the anticoagulation effects of factor Xa inhibitors in most patients with acute major bleeding caused by a factor Xa inhibitor, according to the full data from the ANNEXA-4 study presented at the International Stroke Conference.Īs Cardiology Today previously reported, interim data from ANNEXA-4 indicated that andexanet alfa (Andexxa, Portola) rapidly reversed anti-factor Xa activity in patients with acute major bleeding, and enabled most patients to achieve good to excellent hemostasis.
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