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# Insmed NDA Accepted for Brensocatib
- URL: https://www.fdaweb.com/insmed-nda-accepted-for-brensocatib/
- Published: 2025-02-06T12:00:00.000Z
- Updated: 2026-09-14T14:52:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158612

FDA has accepted for priority review an Insmed NDA for brensocatib for treating patients with non-cystic fibrosis bronchiectasis. The agency has set a review action target date of 8/12.

The submission is based on data from the Phase 3 ASPEN study, which met its primary endpoint with both dosage strengths of brensocatib achieving statistical and clinical significance for reducing the annualized rate of pulmonary exacerbations versus placebo over the 52-week treatment period, according to the company. “Both dosage strengths also met several prespecified exacerbation-related secondary endpoints, including significantly prolonging the time to first exacerbation and significantly increasing the odds of remaining exacerbation-free over the treatment period,” it says. “Patients treated with brensocatib 25 mg also showed significantly lower lung function decline at week 52 as measured by post-bronchodilator forced expiratory volume over one second.”

Brensocatib is described as part of a new class of medicines called dipeptidyl peptidase 1 (DPP1) inhibitors for treating neutrophil-mediated diseases. DPP1 is an enzyme responsible for activating neutrophil serine proteases in neutrophils when they are formed in the bone marrow, the company says. “Neutrophils are the most common type of white blood cell and play an essential role in pathogen destruction and inflammatory mediation,” it says.