Expert Opinion on the Role of Andexanet Alfa


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Mark H Chaitowitz, MD, from the division of hematology at the Albert Einstein College of Medicine in New York, New York, told Hematology Advisor, “I am a strong believer in the superiority of DOACs over warfarin, in multiple respects, including safety. And for the vast majority of patients in whom I start DOAC therapy, absence of an antidote will not influence my decision.”

However, he continued, “For the few patients who express this concern, it’s gratifying to be able to inform them that an antidote is in fact now available [to] dispel some of their anxiety.”

One main limitation of andexanet alfa is the associated cost of therapy ― estimated to be nearly $58,000 for the high dose formulation.

“The extent to which the [emergency department] truly requires this drug in its armamentarium, and whether the overall value it provides to this patient population really justifies its exorbitant price tag, remains to be shown,” said Dr Chaitowitz.

Global Perspective and Moving Forward

The intravenous biologic is currently going through regulatory review in the European Union, with an anticipated approval sometime in 2019.5 Clinical development is also taking place in Japan.

“We cannot at this point assume that andexanet’s ability to reverse anti-factor Xa activity and improve hemostasis automatically translates to benefit in terms of clinical outcomes,” stated Dr Chaitowitz. “We recall that initial enthusiasm for use of activated factor VII in various hemorrhagic scenarios was tempered when clinical data emerged showing no meaningful benefit in clinical endpoints, but an increased risk of thrombosis.”

“In short, it’s nice to have andexanet, but I’m not sure we really need it,” he concluded.

References

1. Hunt BJ, Neal MD, Stensballe J. Spotlight on: reversing anti factor Xa agents and the unmet needs in trauma patients [published online October 11, 2018]. Blood. doi: 10.1182/blood-2018-06-850396

2. Heo YA. Andexanet alfa: first global approval. Drugs. 2018;78(10):1049-1055. doi: 10.1007/s40265-018-0940-4

3. Hunt BJ, Levi M. Urgent reversal of vitamin K antagonists [published online January 4, 2018]. BMJ. doi: 10.1136/bmj.j5424

4. Perzborn E, Roehrig S, Straub A, Kubitza D, Misselwitz F. The discovery and development of rivaroxaban, an oral, direct factor Xa inhibitor. Nat Rev Drug Discov. doi: 10.1038/nrd3185

5. Portola Pharmaceuticals Reports Third Quarter 2018 Financial Results and Provides Corporate Update [news release]. San Francisco, CA: GlobeNewswire; November 7, 2018.