FDA Update – Insmed's Bronchiectasis Drug NDA Under Priority Review

By Bobby Samwell • Monday, February 24 15:17 • Permanent Link

Insmed Incorporated (NASDAQ: INSM) has received an update from the U.S. Food and Drug Administration (FDA) regarding its new drug application (NDA) for brensocatib, a potential treatment for patients with bronchiectasis. The FDA has indicated that it does not currently plan to hold an advisory committee meeting to discuss the NDA, reaffirming that the application is under priority review with a Prescription Drug User Fee Act (PDUFA) target action date of August 12, 2025.

The NDA for brensocatib is based on data from the landmark Aspen study, the largest phase 3 study ever conducted in patients with bronchiectasis. Brensocatib, as an oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1), has the potential to become the first and only approved treatment for bronchiectasis and the first in a new class of medicines called DPP1 inhibitors for the treatment of neutrophil-mediated diseases.

Bronchiectasis is a serious, chronic lung disease affecting approximately 500,000 patients in the U.S., 600,000 patients in the EU5 (France, Germany, Italy, Spain, and UK), and 150,000 patients in Japan. Currently, there are no approved therapies specifically targeting bronchiectasis in these regions.

Insmed is committed to working closely with the FDA to successfully complete the review process for brensocatib and potentially bring forward this much-needed treatment for patients with bronchiectasis.

Insmed Incorporated, headquartered in Bridgewater, New Jersey, is a global biopharmaceutical company with a diverse portfolio of approved and mid* to late-stage investigational medicines, as well as cutting-edge drug discovery focused on serving patient communities where the need is greatest. The company's most advanced programs are in pulmonary and inflammatory conditions, including a therapy approved in the United States, Europe, and Japan to treat a chronic, debilitating lung disease. As a result of these announcements, the company's shares have moved -0.4% on the market, and are now trading at a price of $80.72. For more information, read the company's full 8-K submission here.

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