budiodarone (ATI-2042) / Espero BioPharma - LARVOL DELTA

HARBOR-AF: a multicentre, open-label, dose escalation study of the efficacy, safety, and tolerability of budiodarone for the treatment of subjects with paroxysmal atrial fibrillation (ESC-WCC 2025) - "Conclusion HARBOR-AF is poised to set a new standard of care for non-permanent AF by utilising real-time wearable device monitoring for precise, individualised dose titration. This landmark trial aims not only to control AF symptoms and reduce LEAF but also to potentially modify disease progression, heralding a modern approach to AF management."

Clinical • Atrial Fibrillation • Cardiovascular • Congestive Heart Failure • Heart Failure

XYRA Announces the Issuance of a Fifth New US Patent in a Series of Patents Which Protect the Use of Budiodarone in the Management of Atrial Fibrillation till after 2040 (PRNewswire) - "Five granted US patents align with FDA's guidance and protect the drug and label till after 2040....Having recently received FDA guidance on the approval pathway and a proposed label for budiodarone in the management of AF which will require monitoring with an FDA approved wearable device, the company is now pleased to announce the issuance of a series of new US patents that align with this guidance. The company (XYRA) now has 5 new patents that align with our proposed US label indications (Patent No. 11,759,640) and directions for use (Patent No. 11,839,768) of budiodarone and allow a physician to identify and treat a patient with LEAF with the lowest most effective dose of the drug. Patent No. 12,115,373 instructs a physician treating a patient with non-permanent AF on how to switch a patient from an existing antiarrhythmic drug to an effective dose of budiodarone to eliminate LEAF."

Patent • Atrial Fibrillation

A new paradigm for the management of atrial fibrillation using budiodarone and wearable devices (ESC 2023) - No abstract available

Atrial Fibrillation • Cardiovascular