AstraZeneca will end U.S. commercial sales of Andexxa Dec. 22, citing safety concerns raised in postmarketing data and a recent trial, according to a Dec. 18 FDA news release.
Andexxa, a recombinant factor Xa reversal agent, received accelerated approval in 2018 for patients with life-threatening or uncontrolled bleeding related to rivaroxaban or apixaban. It carried a boxed warning for thromboembolic risk at the time of approval.
In the ANNEXA-I trial, which was submitted to meet post-approval requirements, the Andexxa group presented higher rates of thrombosis (14.6% vs. 6.9%) and thrombosis-related deaths at day 30 (2.5% vs. 0.9%) compared with usual care. Of the 35 patients in the Andexxa group who experienced thrombotic events, 18 (53%) had their events earlier than the one patient in the control group.
Based on these findings, the FDA determined that the risks outweigh the benefits and supported AstraZeneca’s request to voluntarily withdraw the product’s biologics license application. The company will stop manufacturing and selling Andexxa in the U.S., effective Dec. 22.
The agency said it will continue monitoring the safety of all biologic products and provide updates as needed.
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