Insmed Announces FDA Not Holding Advisory Committee Meeting for Brensocatib NDA

Insmed Incorporated (NASDAQ: INSM) announced on February 24, 2025 that the U.S. Food and Drug Administration (FDA) does not currently plan to hold an advisory committee meeting to discuss the company’s New Drug Application (NDA) for brensocatib, intended for the treatment of patients with non-cystic fibrosis bronchiectasis.

The update came as part of the FDA’s Day 74 communication with Insmed. Despite foregoing an advisory committee meeting at this time, the FDA reaffirmed its commitment to review the NDA on a priority basis, setting a Prescription Drug User Fee Act (PDUFA) target action date of August 12, 2025.

Brensocatib, a small molecule and reversible inhibitor of dipeptidyl peptidase 1 (DPP1), is under development as a potential first treatment for bronchiectasis and the first in a new class of DPP1 inhibitors aimed at neutrophil-mediated diseases. The application is supported by data from the landmark ASPEN study, the largest Phase 3 trial ever conducted in patients with bronchiectasis.

Commenting on the update, Chief Medical Officer Martina Flammer, M.D., MBA, stated that the company remains committed to close collaboration with the FDA throughout the review process. “We are very pleased with our ongoing communications with the FDA about the NDA for brensocatib,” she said, underscoring the company’s determination to bring forward a much-needed treatment option for patients affected by this chronic lung disease.

Bronchiectasis is a serious, chronic condition that leads to permanent dilation of the bronchi and is marked by persistent lung infections, inflammation, and lung tissue damage. With approximately half a million patients in the U.S. and significant prevalence in Europe and Japan, the medical community has been awaiting a targeted therapeutic option, as there are currently no approved treatments specifically for this condition.

Insmed’s announcement reflects ongoing regulatory engagement and signals continued momentum as the FDA works toward its review of the NDA under the accelerated timeline associated with priority review designations.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Insmed’s 8K filing here.

Insmed Company Profile

Insmed Incorporated is a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases. Insmed’s first commercial product is ARIKAYCE® (amikacin liposome inhalation suspension), which is approved in the United States for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen for adult patients with limited or no alternative treatment options.