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FDA Approves First Therapy for Bronchiectasis, Transforming Care

The U.S. Food and Drug Administration (FDA) granted approval for brensocatib, marketed as Brinsupri, in August 2025. This marks a significant milestone as it is the first disease-modifying therapy for bronchiectasis. Experts believe this approval will shift the focus of treatment from merely reducing exacerbations to preserving long-term pulmonary health.

In a recent discussion, Dr. Albert Rizzo and Dr. James Chalmers explored how this new therapy may redefine therapeutic goals in the management of bronchiectasis. The approval suggests a potential evolution in clinical trial endpoints, emphasizing disease modification and the slowing of decline. Future evaluations may incorporate advanced measures such as CT imaging and radiographic markers of airway damage, in addition to traditional outcomes like exacerbation rates and lung function.

Dr. Chalmers, who leads respiratory research at the University of Dundee in the UK, anticipates a surge in the recognition and diagnosis of bronchiectasis due to the availability of a targeted therapy. He likened this change to the paradigm shift seen in the treatment of interstitial lung disease following antifibrotic drug approvals. With approximately one million patients affected by bronchiectasis in the United States, he stressed the importance of collaboration among primary care providers, community pulmonologists, and specialty centers.

The introduction of brensocatib should not be seen as a standalone solution. Dr. Chalmers emphasized that it must be integrated into a comprehensive care plan that includes airway clearance strategies, infection management, and an assessment of underlying causes of the disease. He remarked, “I think we’re going to see a lot more attention to bronchiectasis. It’s really been very much a Cinderella condition… and the availability of a new therapy, it gets people interested, it gives people a reason to diagnose it, because there’s something powerful and effective that they can do about it.”

In summary, the approval of brensocatib is expected to significantly impact the management of bronchiectasis. The focus on disease modification could lead to improved patient outcomes and a deeper understanding of this often-overlooked condition. As healthcare providers adjust their approaches, the hope is that this will catalyze greater awareness and better management strategies for those living with bronchiectasis.

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