AstraZeneca Withdraws Factor Xa Reversal Agent From US Market

AstraZeneca ended U.S. commercial sales of the company’s factor Xa reversal agent (Andexxa) on Monday after the Food and Drug Administration issued a safety communication concluding that postmarketing data showed an increased risk of serious and fatal thromboembolic events.

The agency initially granted accelerated approval to the product (coagulation factor Xa [recombinant], inactivated-zhzo) in 2018 for patients treated with rivaroxaban or apixaban who required urgent reversal of anticoagulation due to life-threatening or uncontrolled bleeding. The approval included a boxed warning for thromboembolic risks and a requirement to conduct a randomized controlled trial to verify clinical benefit.

Results from the required trial demonstrated higher rates of thrombosis (14.6% versus 6.9%) and thrombosis-related deaths at 30 days (2.5% versus 0.9%) in patients receiving treatment compared with usual care. Thrombotic events also occurred earlier and more frequently in the treatment group.

Based on available data, FDA concluded that the serious risks outweigh the product’s benefits. AstraZeneca submitted a request to voluntarily withdraw the biologics license application for commercial reasons, and FDA stated it will work with AstraZeneca to keep providers and the public informed as U.S. sales end.