On the safety side, there was no indication in the ANNEXA-4 results of rebound thrombosis with andexanet alfa treatment. The reality is that, despite having treatments that reverse warfarin’s effect, this is often not an easy process in actual practice. A myth exists that reversal agents can easily negate the anticoagulant effect of warfarin. Also, some patients who have opted for treatment with warfarin will switch to a safer class of drugs, the direct factor X a inhibitors. practice, we’ll see an uptick in prescribing of direct factor Xa inhibitors. I think that, once andexanet becomes available for routine U.S. It’s the same with direct factor Xa inhibitors: Some patients are concerned about the lack of a reversal agent, and having such an agent may help increase access to these agents for such patients. They want to know that, if there is bleeding or need for urgent surgery, there is a way to facilitate restoration of hemostasis. That experience shows that patients and providers want the safety net of a reversal agent.

After a reversal agent for dabigatran, idarucizumab (Praxbind) received Food and Drug Administration approval and became available in late 2015, an uptick in dabigatran prescriptions occurred.

We can look at the example of another new oral anticoagulant, dabigatran (Pradaxa), which works by a different mechanism, specifically by inhibiting thrombin. The lack of a reversal agent until now for direct-acting factor Xa inhibitor drugs has probably been a modest but real obstacle to widespread adoption of these agents. Clinicians want to know that you can restore coagulation to a level where you can stop bleeding, and that’s what the results show. Treatment with andexanet alfa produced good or excellent hemostasis in 83% of patients in the ANNEXA-4 study, which is what matters when patients are bleeding.

Andexanet