AstraZeneca says to end U.S. commercial sales of Andexxa

The FDA said in a statement: “Since approval, the FDA has received postmarketing safety data on thromboembolic events, including serious and fatal outcomes, in patients treated with Andexxa. Based on available data, the serious risks including the increase in thromboembolic events are such that the FDA considers the risks of the product to outweigh its benefits. The FDA has communicated this position to AstraZeneca (AZN), and the company has submitted a request to voluntarily withdraw the BLA for the product for commercial reasons. Additionally, the company has confirmed that it will end U.S. commercial sales today, December 22, 2025. Andexxa will no longer be manufactured for or sold in the U.S. by AstraZeneca after December 22, 2025. Continuous monitoring and assessment of the safety of all biological products, including Andexxa, is an FDA priority, and we remain committed to informing the public when we learn new information about these products.”