FDA Approves First-Ever Treatment for Non-Cystic Fibrosis Bronchiectasis

Key Points:
1. First FDA-approved therapy for non-cystic fibrosis bronchiectasis; addresses a major unmet respiratory need.
2. Phase 3 data showed significant reduction in exacerbations in a trial of over 1,700 participants.

On August 12, 2025, the U.S. Food and Drug Administration approved Insmed’s Brinsupri (brensocatib) as the first medicine for non-cystic fibrosis bronchiectasis, a chronic lung disease affecting 350,000 to 500,000 U.S. adults. For decades, treatment options have been limited to antibiotics and airway clearance techniques, which target symptoms rather than underlying inflammation. Brinsupri inhibits DPP1, an enzyme that activates destructive neutrophil proteases, reducing lung tissue damage. In the Phase 3 ASPEN trial involving more than 1,700 participants, patients receiving Brinsupri experienced a significant drop in annualized pulmonary exacerbations compared with placebo. Annual pricing is set at around $88,000 for either the 10 mg or 25 mg dosage. Analysts project peak U.S. sales could reach $3.7 billion by 2031, given the lack of competing drugs. The official prescribing information lists no boxed warnings, which may help drive early adoption among pulmonologists. Advocacy groups are calling it a long-overdue advance for patients who have had no dedicated therapy. Payers are already reviewing coverage policies in anticipation of demand. Insmed plans a broad educational rollout to inform both clinicians and patients. With major competitors like AstraZeneca still years away from approval, Insmed is poised to dominate this emerging market. The approval is also expected to shift how clinical trials in bronchiectasis are designed going forward, with future studies likely focusing on earlier intervention and prevention of exacerbations. Clinicians are already discussing how this option could be integrated into existing care pathways for patients with complex comorbidities. Patient groups have noted the importance of monitoring long-term safety, especially as the drug moves into broader use. Health economists will be watching cost-effectiveness data to guide payer decisions, which could influence uptake in community settings. As post-marketing surveillance ramps up, real-world outcomes will help shape whether this approval becomes a true paradigm shift in respiratory care.

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