Insmed Incorporated announced the U.S. Food and Drug Administration (FDA) approval of BRINSUPRI™ (brensocatib 10 mg and 25 mg tablets), the first approved treatment for non-cystic fibrosis bronchiectasis (NCFB) in adults and children aged 12 and older. As a first-in-class dipeptidyl peptidase 1 (DPP1) inhibitor, BRINSUPRI targets neutrophilic inflammation by inhibiting neutrophil serine proteases, addressing a root cause of airway damage, persistent infections, and exacerbations in NCFB. This chronic condition affects approximately 500,000 diagnosed patients in the U.S. and millions globally, characterized by permanently dilated bronchi, chronic cough, excessive mucus, shortness of breath, and frequent flares that worsen lung function and quality of life.
The approval stems from the Phase 3 ASPEN trial, involving 1,721 patients across 35 countries, which demonstrated that BRINSUPRI 10 mg and 25 mg reduced the annual exacerbation rate by 21.1% and 19.4%, respectively, compared to placebo. Secondary endpoints included prolonged time to first exacerbation, higher exacerbation-free rates, and less decline in post-bronchodilator FEV₁ with the 25 mg dose. Safety data from ASPEN and the Phase 2 WILLOW trial showed common adverse reactions (≥2%) such as upper respiratory tract infection, headache, rash, dry skin, hyperkeratosis, and hypertension, with a higher incidence of gingival and periodontal issues in WILLOW. Warnings include monitoring for dermatologic reactions, gingival issues, and avoiding live attenuated vaccines.
BRINSUPRI is available by prescription via a specialty pharmacy network, supported by Insmed’s inLighten Patient Support Program for access and education. Regulatory submissions are underway with the EMA and MHRA, with planned filing in Japan in 2025 and potential launches in 2026. Insmed hosted a conference call on August 12, 2025, to discuss the approval. This milestone represents a paradigm shift in NCFB management, offering hope to patients facing limited options and disease progression. Forward-looking statements note risks in commercialization, reimbursement, and further trials.
