FDA

Brinsupri approved for non-CF bronchiectasis

August 15, 2025

Brand name: Brinsupri

Generic name: brensocatib

Manufacturer: Insmed

Approval date: August 12, 2025

FDA approved Brinsupri (brensocatib), a dipeptidyl peptidase 1 (DPP1) inhibitor, for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adult and pediatric patients ≥12 years of age.

According to a manufacturer press release, Brinsupri is a first-in-class DPP1 inhibitor, designed to inhibit the activation of enzymes (neutrophil serine proteases) in neutrophils that are key drivers of chronic airway inflammation in NCFB.

Efficacy

Approval was based on data from the phase 3 ASPEN (NCT04594369) and phase 2 WILLOW (NCT03218917) studies. In ASPEN, Brinsupri 10 mg or 25 mg led to a 21.1% and 19.4% reduction in annual rate of exacerbations respectively, compared with placebo. Both dosage strengths of Brinsupri also met several exacerbation-related secondary endpoints, including significantly prolonging time to first exacerbation and significantly increasing the proportion of patients remaining exacerbation-free over the treatment period. Participants who received Brinsupri 25 mg experienced statistically significant less decline in lung function, as measured by post-bronchodilator FEV₁, at week 52.

Safety

The most common adverse reactions (≥2%) in the ASPEN trial included upper respiratory tract infection, headache, rash, dry skin, hyperkeratosis, and hypertension. The safety profile for adult patients with NCFB in WILLOW was generally similar to ASPEN, except for a higher incidence of gingival and periodontal adverse reactions in WILLOW.

Sources:

FDA approves Brinsupri™ (brensocatib) as the first and only treatment for non-cystic fibrosis bronchiectasis, a serious, chronic lung disease. [News release]. 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

Brinsupri (brensocatinib) [package insert]. Insmed. https://insmed.com/pdf/brinsupri_full_prescribing_information.pdf Revised August 2025. Accessed August 14, 2025.