XYRA LLC, a private biopharmaceutical company focused on developing innovative therapies for cardiac rhythm disorders, is pleased to announce an agreement with the FDA regarding the next steps for its drug budiodarone in treating symptomatic non-permanent atrial fibrillation (AF).

The agreement, reached during a series of End of Phase 2 (EoP2) meetings, outlines the pivotal studies needed for the drug's approval and labeling. These studies are aimed at addressing the significant unmet need in managing AF, particularly in patients with symptomatic non-permanent AF, including paroxysmal (PAF) and persistent cases characterized by long episodes of atrial fibrillation (LEAF) lasting longer than 5.5 hours.

Of the 7 million diagnosed AF patients in the US, approximately half suffer from non-permanent AF, with the most severe cases progressing to untreatable permanent AF. Two key studies have been agreed upon by XYRA and the FDA. The first study involves a long-term dose titration exploration of budiodarone, guided by the use of FDA-approved wearable AF monitoring devices. This study aims to establish the lowest effective dose for individuals, achieving symptom control and eliminating LEAF of any duration.

The second pivotal study is a six-month double-blind randomized controlled trial comparing budiodarone against placebo in subjects with symptomatic non-permanent AF and LEAF exceeding 5.5 hours. Success in this study will be measured by symptom control and the proportion of subjects achieving a predefined threshold for AF stroke risk reduction by eliminating LEAF >5 hours, as monitored by validated wearable devices.

The agreement also acknowledges the necessity of wearable device monitoring for dose optimization, potentially streamlining the approval process. Pending the drug's continued safety and efficacy in the pivotal studies and additional evaluations, approval may align with International Conference on Harmonization (ICH) guidance.

Dr. Peter Milner, Managing Member of XYRA, expressed gratitude to the FDA for their guidance during the EoP2 meetings. He emphasized the importance of integrating FDA-approved wearable AF monitoring devices in identifying eligible subjects and establishing optimal doses. XYRA looks forward to collaborating with the FDA to demonstrate the safety and efficacy of budiodarone in addressing the unmet needs of patients with symptomatic non-permanent AF.

 

Source: prnewswire.com

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