FDA Raises Safety Concerns Over AstraZeneca’s Andexxa Ahead of Advisory Committee Meeting
FDA Safety Concerns:
The FDA has raised safety questions about AstraZeneca's Andexxa, a bleeding reversal agent, ahead of an advisory committee meeting. The concerns include increased rates of dangerous clotting and clotting-related deaths observed in a trial1.
Background:
Andexxa (andexanet alfa) is used to reverse the anticoagulation effects of direct oral Factor Xa inhibitors, such as apixaban and rivaroxaban, in patients experiencing life-threatening or uncontrolled bleeding. It received accelerated approval in 201823.
Clinical Trials:
The ANNEXA-I trial, a post-marketing Phase IV study, was stopped early after achieving pre-specified criteria for superior haemostatic efficacy compared to usual care. However, the FDA is now scrutinizing the safety data, particularly the incidence of thromboembolic events and deaths23.
Regulatory Filings:
AstraZeneca plans to proceed with regulatory filings in the US and EU to convert Andexxa's conditional approval to full approval, despite the FDA's safety concerns2.
Adverse Reactions:
Common adverse reactions to Andexxa include urinary tract infections and pneumonia. The drug has also been associated with serious and life-threatening adverse events, such as arterial and venous thromboembolic events, ischemic events, cardiac arrest, and sudden deaths35.
Urgent Need:
There is an urgent need for specific reversal agents for patients treated with Factor Xa inhibitors, as major bleeding can be life-threatening and may not be visible25.
Advisory Committee Meeting:
The FDA will convene an advisory committee to discuss the safety and efficacy of Andexxa, focusing on the recent safety concerns1.
Sources:
1. https://endpts.com/fda-raises-safety-questions-on-astrazenecas-bleeding-reversal-agent/
2. https://www.astrazeneca.com/media-centre/press-releases/2023/andexxa-phase-iv-trial-stopped-early-after-achieving-pre-specified-criteria-on-haemostatic-efficacy-versus-usual-care.html