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华尔街日报FDA Flags Deadly Risks, AstraZeneca Pulls Andexxa From US Market
The U.S. Food and Drug Administration (FDA) said the safety risks associated with Andexxa now outweigh its benefits, prompting AstraZeneca Plc (NASDAQ:AZN) 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.
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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.
AstraZeneca To Exit U.S. Market
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 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.
ANNEXA-I Clinical Findings and Safety Risks
As a condition of approval, AstraZeneca 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 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.
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