Insmed Incorporated receives FDA Priority Review for Brensocatib NDA

Insmed Incorporated recently announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for brensocatib for patients with non-cystic fibrosis bronchiectasis. This NDA acceptance includes a Priority Review designation granted by the FDA, setting a target action date of August 12, 2025, under the Prescription Drug User Fee Act (PDUFA).

“Bronchiectasis is a chronic, progressive disease with no approved treatments, leaving hundreds of thousands of people in the U.S. without an effective way to reduce the pulmonary exacerbations that can lead to serious consequences,” noted Martina Flammer, M.D., MBA, Chief Medical Officer of Insmed. “Brensocatib has the potential to transform the treatment landscape for bronchiectasis, and we were pleased to receive the FDA’s acceptance of our NDA with Priority Review even earlier than anticipated.”

The NDA submission is supported by data from the Phase 3 ASPEN study, demonstrating significant reductions in the annualized rate of pulmonary exacerbations with brensocatib compared to a placebo over a 52-week treatment period. Additionally, brensocatib showed positive results in various secondary endpoints related to exacerbations and lung function decline.

Brensocatib, if approved, could become the first and only treatment for bronchiectasis and the first in a new class of medicines called dipeptidyl peptidase 1 (DPP1) inhibitors for neutrophil-mediated diseases. The FDA’s Priority Review signifies that the drug, if cleared, would offer a significant enhancement in treating a serious condition.

Insmed’s plans for regulatory submissions in the EU, UK, and Japan in 2025, with anticipated commercial launches in 2026, remain subject to the respective approval processes in each region.

About Insmed
Insmed Incorporated is a leading global biopharmaceutical company dedicated to providing top-tier therapies to patients with severe illnesses. The company focuses on a varied portfolio of approved and late-stage investigational drugs, with a primary focus on pulmonary and inflammatory conditions.

In compliance with the SEC’s regulations, the contents of this announcement, including Exhibit 99.1, should not be considered as “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 or incorporated by reference into any filings under the Securities Act of 1933 or the Exchange Act, except where expressly noted with specific reference in such documents.

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.

About Insmed

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.