FDA Reaches Agreement on Endpoints for Approval of Budiodarone for the Management of Atrial Fibrillation

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XYRA has announced that it has reached an agreement with FDA on the key studies that will form the basis of approval and labeling of orally administered budiodarone for the long-term management of symptomatic non-permanent atrial fibrillation (AFib) following a series of Phase II meetings, according to a company press release.¹

AFib, the most common type of arrythmia, is a type of irregular heartbeat that can lead to cardiac events, such as stroke and blood clots, if not treated. The CDC predicts that by 2030, approximately 12.1 million people in the United States will have developed the condition. Further, in 2019, AFib was mentioned on 183,321 death certificates in the United States was listed as the underlying cause of death for 26,535 of those cases.²

According to the press release, the evidence from outcomes studies suggests patients with symptomatic non-permanent AFib, whether paroxysmal (PAF) or persistent, characterized by long episodes of atrial fibrillation (LEAF) lasting longer than 5.5 hours are at highest risk for stroke, heart failure and progression to permanent AFib. FDA has agreed that reducing LEAF could reduce progression to permanent AFib, recently approving a number of wearable AFib monitoring devices.

"Budiodarone is a potentially best-in-class mixed ion channel blocker with features that are designed to enhance safety and efficacy in the treatment of symptomatic non-permanent AFib.We wish to thank the Agency (FDA) for a timely and successful series of EoP2 meetings at which we obtained clear, specific, and useful guidance on the pathway to approval. Integrating FDA approved and validated wearable AFib monitoring devices into the development will allow us to identify eligible subjects and ensure they are then established on the lowest effective approved dose," said Peter Milner MD, FACC, managing member, XYRA in the press release. "We look forward to collaborating with the Agency to demonstrate budiodarone is both safe and effective for the management of symptomatic non-permanent AFib. This is a sizable and growing population with an unmet need and includes subjects with persistent AFib that can be cardioverted, and those with PAF at high risk because of LEAF that is refractory to other therapies."

Of the two key studies XYRA and FDA agreed upon, the first is an open label, long term dose titration study of the 4 doses of budiodarone that were effective in Phase II. Dosing will be guided by the use of an FDA approved wearable device to monitor safety and effectiveness in the Phase III trial. The second is a 6 month double blind randomized controlled trial of the 4 fixed active doses of budiodarone versus placebo in 500 subjects with symptomatic non-permanent AF and LEAF lasting longer than 5.5 hours.

References

1. XYRA Announces Successful FDA End of Phase 2 Meeting and Agreement on Endpoints for Approval of Budiodarone for the Management of Atrial Fibrillation. News release. February 26, 2024. Accessed February 26, 2024. https://www.prnewswire.com/news-releases/xyra-announces-successful-fda-end-of-phase-2-meeting-and-agreement-on-endpoints-for-approval-of-budiodarone-for-the-management-of-atrial-fibrillation-302070506.html
2. US Centers for Disease Control and Prevention. Atrial Fibrillation. Webpage. Updated October 14, 2022. Accessed February 26, 2024. https://www.cdc.gov/heartdisease/atrial_fibrillation.htm