FDA Approves First-Ever Drug for Chronic Inflammatory Lung Disease Affecting Millions

nature.com

In a momentous advance for respiratory health, the FDA has approved Brensocatib as the first and only agent specifically for treatment of non-cystic fibrosis bronchiectasis, a serious, chronic lung disease that is infrequently recognized.

Bronchiectasis is now affecting millions of individuals across the globe. The disease is characterized by a chronic cough, repeated infections in the lungs, and permanent damage to airways. While patients previously had symptomatic treatment options, there have been no drugs with mechanisms addressing the causes of the condition, as such a severe disease with a 5-year mortality rate greater than 30% in severe cases, and is frequently not recognized until years later.

Brensocatib, a once daily oral agent, addresses neutrophilic inflammation which is one large contributor to disease progression and flare-ups. This approval, described as a "paradigm shift" by NYU’s Dr. Doreen Addrizzo-Harris, represents the first time a therapy disrupted a key driver in the overall bronchiectasis process.

Brensocatib, which will be marketed as Brinsupri in Europe, provides hope to thousands of patients who have grappled with limited treatment headway, until now.

This is a tremendous leap forward in the treatment of chronic lung disease and for patients that are finally recognized and addressed.

References:

https://www.nature.com/articles/d41573-025-00135-6

https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/217673s000lbl.pdf