FDA Approves Brensocatib for Non–Cystic Fibrosis Bronchiectasis: Daily Dose

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On August 14, 2025, we reported on the US FDA approval of brensocatib (BRINSUPRI™) 10 mg and 25 mg tablets as the first treatment for non–cystic fibrosis bronchiectasis (NCFB) in persons aged ≥12 years.

The approval

Brensocatib is a first-in-class, once-daily oral dipeptidyl peptidase 1 (DPP1) inhibitor that targets neutrophil serine proteases, key drivers of airway inflammation in NCFB. The approval was supported by data from the phase 3 ASPEN and phase 2 WILLOW trials, both published in The New England Journal of Medicine.

In ASPEN, annual exacerbation rates were reduced by 21.1% with brensocatib 10 mg and 19.4% with 25 mg compared with placebo. Secondary endpoints showed prolonged time to first exacerbation, a higher proportion of patients remaining exacerbation-free, and less decline in forced expiratory volume in 1 second (FEV₁) at 52 weeks in the 25 mg group. The most common adverse reactions (≥2%) included upper respiratory tract infection, headache, rash, dry skin, hyperkeratosis, and hypertension.

WILLOW results demonstrated similar efficacy and safety findings, though gingival and periodontal adverse events were reported more frequently.

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