Bleeding reversal agent pulled from market over FDA’s safety concerns

AstraZeneca has pulled Andexxa, a factor Xa inhibitor bleeding reversal agent, from the U.S. market, according to a new update from the U.S. Food and Drug Administration (FDA). As of Monday, Dec. 22, commercial sales of the drug are officially done.

The FDA first approved Andexxa in 2018 to treat patients who have been treated with rivaroxaban or apixaban and require an anticoagulation reversal due to life-threatening or uncontrolled bleeding event. It was an accelerated approval based on the understanding that AstraZeneca would conduct a randomized controlled trial to confirm the reversal agent’s clinical benefits. 

When that clinical trial, ANNEXA-1, was completed and published in The New England Journal of Medicine in 2024, it confirmed that Andexxa was linked to an improved control of hematoma expansion compared to usual care.[1] However, that trial also pointed to potential risks. For example, thrombotic events occurred in 10.3% of patients given the reversal agent and 5.6% of patients given usual care. The ischemic stroke rates, meanwhile, were 6.5% for the reversal agent patients and 1.5% for the usual care patients. The FDA’s Cellular, Tissue and Gene Therapies Advisory Committee met in November 2024 to discuss those findings. 

After reviewing the data in great detail, the FDA ultimately ruled that the risks of treatment with this reversal agent outweigh any benefits.

“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,” according to an FDA advisory.