<div id="readability-page-1">The U.S. Food and Drug Administration (FDA) said the safety risks associated with Andexxa now outweigh its benefits, prompting AstraZeneca ( AZN ) Plc to seek a voluntary withdrawal of the drug’s biologics license and plan an exit from the U.S. market. In November 2024, the Cellular, Tissue, and Gene Therapies Advisory Committee discussed a supplemental biologics license application for Andexxa. Before the meeting, the FDA panel released brief documents highlighting some safety issues and other concerns. Also Read: Drugmakers Briefed As Vaccine Skeptics Like RFK Jr. Probe RSV Therapy Risks The FDA on Thursday said it reviewed postmarketing safety data showing thromboembolic events, including serious and fatal cases, in patients treated with Andexxa. Based on this evidence, the agency concluded that the product’s risk profile is no longer favorable and communicated its position to AstraZeneca ( AZN ). <h2>AstraZeneca To Exit U.S. Market</h2> In response, the company requested to voluntarily withdraw the biologics license application for commercial reasons and confirmed it will end U.S. commercial sales by Dec. 22, 2025. AstraZeneca ( AZN ) said Andexxa will no longer be manufactured for or sold in the U.S. after that date. Andexxa received accelerated approval in 2018 as a recombinant modified human factor Xa protein designed to reverse anticoagulation in patients treated with rivaroxaban or apixaban who experience life-threatening or uncontrolled bleeding. At approval, the product carried a boxed warning highlighting thromboembolic risks. The accelerated approval was based on reductions in anti–factor Xa activity, a surrogate endpoint considered reasonably likely to predict clinical benefit. <h2>ANNEXA-I Clinical Findings and Safety Risks</h2> As a condition of approval, AstraZeneca ( AZN ) was required to conduct a randomized controlled trial to confirm clinical benefit in patients with intracerebral hemorrhage. That requirement was addressed through the ANNEXA-I trial, results of which were submitted in a supplemental biologics license application in January 2024. The FDA later convened an advisory committee meeting in November 2024 to review the findings. Data from the trial showed a higher rate of thrombosis in patients treated with Andexxa compared with usual care, including more thrombosis-related deaths by Day 30. More than half of the thrombotic events in the Andexxa arm occurred earlier than those observed in the control group. AZN Price Action: AstraZeneca ( AZN ) shares were down 0.28% at $91.10 at the time of publication on Monday. The stock is approaching its 52-week high of $94.01, according to Benzinga Pro data. Read Next: <ul> <li>Honeywell’s Legal Bill And Outlook Cut Rattle Investors</li> </ul> Photo by Robert Way via Shutterstock</div>

阿斯利康

阿斯利康制药

阿斯利康将在美国停止销售 Andexxa，因为 FDA 认为其安全风险超过了益处。FDA 的审查显示，使用 Andexxa 的患者出现了严重的血栓栓塞事件。阿斯利康计划在 2025 年 12 月 22 日前撤回生物制品许可证并结束美国销售。Andexxa 于 2018 年获得批准，旨在逆转有生命危险的出血患者的抗凝状态。临床试验显示血栓发生率较高，促使其撤回。阿斯利康的股价下跌 0.28%，至 91.10 美元

FDA 警示致命风险，阿斯利康从美国市场撤回 Andexxa