ANNEXA 4
An interim analysis of ANNEXA 4 will shed light on the safety of andexanet alfa, a novel potential reversal agent for patients on direct oral anticoagulants who are experiencing an acute major bleed.
ANNEXA 4 (Prospective, Open-Label Study of Andexanet Alfa in Patients Receiving a Factor Xa Inhibitor Who Have Acute Major Bleeding) is an ongoing phase 3b/4 trial of the novel agent, a modified form of the human factor Xa molecule. Interim results showed that, at 12 hours after infusion, 37 of 47 patients in the efficacy analysis achieved excellent or good hemostasis.
Dr. Stuart J. Connolly
The Food and Drug Administration is currently reviewing andexanet alfa, and a decision is expected this May.
Stuart J. Connolly, MD, of McMaster University, Hamilton, Ont., will present the report at the Fifth Late-Breaking Clinical Trial Session on Monday, 10:45 a.m.-11:45 a.m., in the Main Tent.