Insmed Secures FDA Approval for First DPP1 Inhibitor in Lung Disease

The FDA has approved Insmed's Brensocatib (Brinsupri), making it the first dipeptidyl peptidase 1 (DPP1) inhibitor authorized for use in any disease and the first approved therapy for non–cystic fibrosis bronchiectasis135.

Brensocatib targets DPP1, an enzyme that activates neutrophil serine proteases, thereby reducing neutrophil-mediated inflammation and tissue damage, which are key drivers in bronchiectasis progression3.

Clinical trial data (ASPEN Phase III) shows Brensocatib lowered the rate of pulmonary exacerbations by around 20% compared to placebo; previous studies (WILLOW Phase II) showed approximately 40% reduction1.

This treatment addresses a significant unmet need, as bronchiectasis previously had no approved therapies for hundreds of thousands of U.S. patients34.

Brensocatib's approval is seen as a potential paradigm shift, offering hope for improved management and standard of care in neutrophil-mediated lung diseases3.

Insmed plans to commercialize Brinsupri without a major pharma partner and is preparing manufacturing and launch operations, aided by a recent capital raise of $750 million1.

Sources:

1. https://www.biospace.com/fda/insmed-wins-approval-for-first-bronchiectasis-drug-and-dpp1-blocker

3. https://www.ajmc.com/view/brensocatib-becomes-first-fda-approved-therapy-for-bronchiectasis

4. https://www.prnewswire.com/news-releases/fda-grants-priority-review-to-insmeds-brensocatib-for-treatment-of-bronchiectasis-with-pdufa-target-action-date-set-for-august-12-2025-302369466.html

5. https://www.statnews.com/2025/08/12/insmed-lung-disease-drug-approved/