Andexxa (andexanet) is a treatment currently used when the reversal of anticoagulation is needed for life-threatening or uncontrolled bleeding in patients who are using Eliquis (apixaban) or Xarelto (rivaroxaban) at the time. Andexxa drug injury lawsuits for patients who developed blood clots involving a pulmonary embolism (PE) or deep vein thrombosis (DVT) may be coming after a November 2024 FDA Advisory Committee meeting.
From a December 17, 2024, FirstWord PHARMA news report, “Fate of AstraZeneca’s Andexxa unclear as FDA rejects full approval”:
Less than a month after a bruising FDA advisory committee meeting, the agency has issued a complete response letter (CRL) regarding AstraZeneca’s bid to convert its anticoagulant reversal drug Andexxa (andexanet alfa) from accelerated to full approval.
The fate of Andexxa is unclear at this stage; the FDA could seek withdrawal of the drug or ask for additional confirmatory data. AstraZeneca told FirstWord that “while discussions with the FDA are ongoing, Andexxa will remain on the US market.”…
However, at last month’s advisory meeting while discussing data from the ANNEXA-I confirmatory trial, panel members grappled with whether Andexxa’s demonstrated benefits outweigh its risks. Ahead of the meeting, FDA reviewers highlighted “major safety findings,” including a 14.6% thrombosis rate in the Andexxa arm of the study compared with 6.9% in the control group, along with higher thrombosis-related deaths.
Of course, for the Andexxa drug injury lawsuits to be successful, these blood clot side effects would have to occur before any AstraZeneca drug recall for Andexxa because the patients would have to be using this anticoagulant reversal drug at the time of their PE or DVT diagnosis.
As seen above and below, whether there will be an AstraZeneca drug recall of Andexxa is unclear. Some possibilities are that the FDA will seek withdrawal of this AstraZeneca anticoagulant reversal drug or request additional confirmatory data for Andexxa.
From a December 13, 2024, Pink Sheet news report, “AstraZeneca Says Andexxa Will Not Convert To Full Approval, Quietly Reveals Complete Response”:
The next steps for the drug following the [FDA-issued complete response letter [(CRL)], which has not been publicly announced by the company, are unclear. Neither AstraZeneca nor FDA would provide much additional information about the product’s standing….
The agency could move to withdraw the drug from the market or ask the company to conduct additional studies to verify a favorable risk-benefit balance.
AstraZeneca told the Pink Sheet that the drug will remain on the US market while discussions with the agency about next steps continue. But the company would not comment on whether those discussions include potential new trials.
We are investigating possible Andexxa drug injury lawsuits that would be filed against AstraZeneca for patients who developed a pulmonary embolism (PE) or deep vein thrombosis (DVT) while they were using Andexxa.
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