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BRIDGEWATER, N.J. – August 12, 2025 – The U.S. Food and Drug Administration (FDA) has granted approval to Insmed Incorporated for its groundbreaking drug, BRINSUPRI™ (brensocatib), making it the first and only approved treatment for non-cystic fibrosis bronchiectasis (NCFB). This approval marks a significant milestone for the hundreds of thousands of people in the U.S. living with this serious and chronic lung disease, which previously had no approved therapeutic options.
NCFB is a progressive inflammatory lung disease characterized by permanently widened airways, which makes it difficult to clear mucus and bacteria. This leads to persistent infections and inflammation, chronic cough, shortness of breath, and repeated respiratory flare-ups that can cause irreversible lung damage and decline in lung function.
BRINSUPRI is a first-in-class dipeptidyl peptidase 1 (DPP1) inhibitor. It works by targeting and inhibiting the activation of enzymes in white blood cells (neutrophils) that are key drivers of the chronic inflammation associated with NCFB. The FDA’s decision was supported by data from the Phase 3 ASPEN trial, which demonstrated that the drug significantly reduced the annual rate of pulmonary exacerbations compared to a placebo.
The approval covers both adults and adolescents aged 12 and older. The company has stated that the drug is now available in the U.S. by prescription through a specialty pharmacy network. The approval of BRINSUPRI is expected to bring new hope to patients and clinicians seeking to manage this challenging condition.
Disclaimer: This news article is intended for informational purposes only and does not constitute medical advice. Consult with a healthcare professional for diagnosis and treatment.
Reference:
- Reuters. “U.S. FDA approves Insmed’s drug, the first treatment for chronic lung disease.” August 12, 2025. https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-insmeds-drug-first-treatment-chronic-lung-disease-2025-08-12/
