The FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee recently discussed the increased risk of Andexxa blood clots and clotting-related deaths seen in the ANNEXA-I trial done for Andexxa, compared with a standard of care reversal agent.
This Andexxa Advisory Committee considered the current drug safety profile of Andexxa in the context of this Draft Discussion Question about Andexxa blood clots and clotting-related deaths presented in the FDA Briefing Document for its November 21, 2024 meeting:
ANNEXA-I demonstrated an increased incidence of thrombosis (15.1% versus 6.9%) and thrombosis-related deaths at Day 30 (2.5% versus 0.9%) in the [Andexxa (andexanet)] arm compared to the [usual care (UC)]. Are the serious risks of [Andexxa (andexanet)] acceptable in the indicated population and in the context of the benefit demonstrated in ANNEXA-I?
For some contextual information, we turn to this November 19, 2024 Endpoints News report “Ahead of adcomm, FDA raises safety questions for AstraZeneca’s reversal agent for life-threatening bleeds”, by Zachary Brennan, Senior Editor:
[Andexxa (andexanet)], a recombinant modified human factor Xa protein, is for patients treated with [Xarelto (rivaroxaban)] or [Eliquis (apixaban)] when rapid reversal of anticoagulation is needed because of life-threatening or uncontrolled bleeding. That could include, for example, when a patient needed urgent surgery because of a medical emergency or accident.Last year, AstraZeneca began plans to shift Andexxa to a full approval from its accelerated approval after halting its confirmatory trial early due to these efficacy findings.
But FDA explained how the confirmatory trial, known as ANNEXA-I, revealed “major safety findings” including a “doubling of the rate of thromboses and thrombosis related deaths at Day 30 in the [Andexxa (andexanet)] arm compared with” a standard of care clotting agent known as a prothrombin complex concentrate.
Of the 239 patients treated with [Andexxa (andexanet)], FDA said, 14.6% of patients suffered thrombotic events versus 6.9% in the standard of care arm.
There has been speculation that this increased risk of Andexxa blood clots and clotting-related deaths might lead to an eventual drug recall. For example, the headline for an article published November 20, 2024, by Pink Sheet is “AstraZeneca’s Andexxa Could Be Headed For Withdrawal After US FDA’s Negative Advisory Committee Preview”.
We will continue to monitor this emerging drug safety issue of Andexxa blood clots and clotting-related deaths.
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