FDA Approves Brensocatib for Non–Cystic Fibrosis Bronchiectasis

The US FDA has approved brensocatib (BRINSUPRI™) 10 mg and 25 mg tablets as the first treatment for non–cystic fibrosis bronchiectasis (NCFB) in adults and adolescents aged ≥12 years, according to an announcement from Insmed Incorporated.

NCFB is a progressive lung disease affecting approximately 500 000 people in the US. It is characterized by permanent widening of the bronchi, impaired mucus clearance, chronic infection, and persistent inflammation. Patients frequently experience exacerbations marked by cough, increased sputum production, dyspnea, and fatigue, which can accelerate lung function decline.

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.

“Non–cystic fibrosis bronchiectasis deeply affects the lives of people living with this chronic lung condition, impacting both their physical health and emotional well-being,” Elisha Malanga, executive director of the Bronchiectasis and NTM Association said in a press release. “The FDA approval of brensocatib represents a significant and long-awaited advancement as the first approved therapy for non–cystic fibrosis bronchiectasis.”

Brensocatib will be available in the US by prescription through a specialty pharmacy network. Regulatory applications are under review with the European Medicines Agency and the UK’s Medicines and Healthcare products Regulatory Agency, with a filing in Japan planned for 2025.

Source: FDA Approves BRINSUPRI™ (brensocatib) as the First and Only Treatment for Non-Cystic Fibrosis Bronchiectasis, a Serious, Chronic Lung Disease. News release. August 12, 2025. Accessed August 14, 2025. https://investor.insmed.com/2025-08-12-FDA-Approves-BRINSUPRI-TM-brensocatib-as-the-First-and-Only-Treatment-for-Non-Cystic-Fibrosis-Bronchiectasis,-a-Serious,-Chronic-Lung-Disease