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FDA Denies Full Approval for Andexxa Following Dosing Uncertainties

  • The FDA has denied full approval for andexanet alfa (Andexxa), following an advisory committee's concerns about optimal dosing and patient selection criteria.

  • Boston Scientific's Accolade pacemakers face a recall due to increased risk of permanently entering "safety mode," potentially requiring early device replacement.

  • Questions have emerged regarding the PLATO trial of ticagrelor (Brilinta), with a BMJ investigation raising concerns about potential study unblinding and methodology.

The U.S. Food and Drug Administration (FDA) has declined to grant full approval for andexanet alfa (Andexxa), marking a significant setback in the advancement of anticoagulant reversal agents. This decision comes approximately one month after an advisory committee highlighted substantial uncertainties regarding optimal dosing strategies and patient selection criteria.

Regulatory Context and Clinical Implications

The rejection reflects ongoing concerns about determining the most effective dose of andexanet alfa and identifying which patient populations would benefit most from the treatment. The drug, developed to reverse the effects of Factor Xa inhibitors, has been available under accelerated approval, but questions remain about its optimal clinical application.

Safety Concerns in Cardiac Devices

In a parallel development, the FDA has issued an alert regarding Boston Scientific's Accolade pacemakers. The devices are being recalled due to an increased risk of permanently entering "safety mode," a malfunction that could necessitate premature device replacement. This recall highlights the ongoing challenges in maintaining the safety and reliability of cardiac implantable electronic devices.

Clinical Trial Integrity Under Scrutiny

Adding to the cardiovascular news landscape, the British Medical Journal (BMJ) has published an investigation that raises fresh concerns about the PLATO trial, which evaluated ticagrelor (Brilinta). The investigation not only resurrects previous doubts about the study but also introduces new questions regarding potential unblinding in the trial methodology, potentially affecting the integrity of the results.

Advancing Cardiovascular Technologies

Despite these challenges, the field continues to see technological progress. The FDA has cleared the BPM Pro 2 blood pressure monitor, manufactured by Withings Health Solutions. This new device promises more precise and clinically meaningful blood pressure and pulse rate measurements, representing an advancement in cardiovascular monitoring technology.

Future Implications

These developments underscore the complex landscape of cardiovascular medicine, where regulatory oversight, device safety, and clinical trial integrity intersect. The FDA's decision on andexanet alfa particularly highlights the agency's commitment to ensuring thorough validation of both dosing protocols and patient selection criteria before granting full approval to novel therapeutic agents.
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Reference News

[1]
Recalled Pacemakers; FDA Rejects Full Andexxa Approval; Ticagrelor Back in Hot Seat
medpagetoday.com · Dec 17, 2024

The FDA recalls Boston Scientific's Accolade pacemakers due to safety mode risks. Withings Health Solutions announces FD...

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