James Chalmers, MBChB, PhD

Chalmers discussed how brensocatib’s potential approval may transform the currently empty treatment landscape for bronchiectasis.

Investigating Brensocatib, Potential First Treatment for Bronchiectasis, with James Chalmers, MBChB, PhD

The FDA has accepted and granted priority review to Insmed’s New Drug Application (NDA) for brensocatib, a potential first treatment for patients with non-cystic fibrosis bronchiectasis. The therapy has a Prescription Drug User Fee Act (PDUFA) of August 12, 2025.

The NDA submission was based on data from the landmark Phase 3 ASPEN study, which met its primary endpoint of clinically and statistically significantly reducing the annualized rate of pulmonary exacerbations compared with placebo over 52 weeks in both its 10 and 25 mg dosages. The study assessed brensocatib 10 mg, brensocatib 25 mg, or placebo once daily for 52 weeks, followed by 4 weeks off treatment, in adults and adolescents.

® spoke with James Chalmers, MBChB, PhD, Professor, Asthma and Lung UK Chair of Respiratory Research, MBChB, PhD, FRCPE, FERS, Clinical Professor (Teaching and Research) of Respiratory Research, Respiratory Medicine and Gastroenterology, University of Dundee, United Kingdom, who served as a primary investigator on the ASPEN study, to learn more about bronchiectasis and its unmet needs in the field. He discussed brensocatib and how it may benefit patients with bronchiectasis as the potential first treatment to be approved for the condition.

“[Bronchiectasis has] been neglected, a bit of a Cinderella condition. In 2011 the European Respiratory Society… described bronchiectasis as the most neglected disease in respiratory medicine, because there's so many patients, but nobody was really doing research into it, and nobody, nobody was doing any clinical trials. And so, it's really exciting that that's now changing, because our patients really need it to change. And this [potential] first licensed therapy is a step towards addressing that major burden,” Chalmers told 

Chalmers shared his excitement for the potential FDA approval of brensocatib and also discussed some priorities in bronchiectasis research and care that will follow after getting a first treatment.

FDA Grants Priority Review to Insmed's Brensocatib for Treatment of Bronchiectasis with PDUFA Target Action Date Set for August 12, 2025. News release. Insmed. February 6, 2025. https://www.prnewswire.com/news-releases/fda-grants-priority-review-to-insmeds-brensocatib-for-treatment-of-bronchiectasis-with-pdufa-target-action-date-set-for-august-12-2025-302369466.html

James Chalmers, MBChB, PhD

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