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# No Panel Meeting for Brensocatib NDA
- URL: https://www.fdaweb.com/no-panel-meeting-for-brensocatib-nda/
- Published: 2025-02-24T12:00:00.000Z
- Updated: 2026-09-14T14:53:47.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158709

FDA has told Insmed that it does not currently plan to hold an advisory committee meeting to discuss the company’s NDA for brensocatib for patients with non-cystic fibrosis bronchiectasis. Insmed says brensocatib is the first in a new class of medicines called dipeptidyl peptidase 1 (DPP1) inhibitors for treating neutrophil-mediated diseases. The user fee review action target date is 8/12.

The submission is based on data from the [landmark ASPEN Phase 3 study](https://c212.net/c/link/?t=0&l=en&o=4367951-1&h=3139195134&u=https%3A%2F%2Finvestor.insmed.com%2F2024-05-28-Insmed-Announces-Positive-Topline-Results-from-Landmark-ASPEN-Study-of-Brensocatib-in-Patients-with-Bronchiectasis&a=landmark+ASPEN+study&ref=fdaweb.com), which met its primary endpoint with both dosage strengths of brensocatib achieving statistical and clinical significance in 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.