FDA Approves Insmed's Brinsupri for Non-Cystic Fibrosis Bronchiectasis Treatment

Insmed has received FDA approval for Brinsupri, a treatment for non-cystic fibrosis bronchiectasis. The chronic lung disease affects approximately 500,000 people in the US and can cause permanent lung damage. Brinsupri is available in the US by prescription and submissions for approval are underway in Europe, the UK, and Japan.

Insmed (Nasdaq: INSM) has achieved a significant milestone with the FDA approval of Brinsupri (brensocatib) for non-cystic fibrosis bronchiectasis (NCFB). This approval marks the first and only treatment for NCFB in adults and children 12 years and older, addressing a market of approximately 500,000 diagnosed patients in the US.

Brinsupri, a first-in-class oral dipeptidyl peptidase 1 (DPP1) inhibitor, targets neutrophilic inflammation, a root cause of bronchiectasis exacerbations. The approval is supported by Phase 3 ASPEN and Phase 2 WILLOW studies, demonstrating a 21.1% reduction in annual exacerbation rates at 10mg and 19.4% at 25mg compared to placebo [1].

The drug is now available in the US through specialty pharmacies, and Insmed has regulatory applications pending with the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA), with plans to file in Japan in 2025. This global strategy could significantly expand the addressable patient population beyond the US market.

For investors, the approval of Brinsupri presents a substantial commercial opportunity. With no competitive products, Brinsupri enters as both first and best-in-class, with patent protection likely extending well into the next decade. Insmed's established specialty pharmacy distribution network suggests they are well-prepared for commercialization.

Looking ahead, Insmed will host an investor conference call today at 12:00 PM ET to discuss the FDA approval [2].

References:
[1] https://www.stocktitan.net/news/INSM/fda-approves-brinsupritm-brensocatib-as-the-first-and-only-treatment-lffhtcma3mf5.html
[2] https://www.morningstar.com/news/pr-newswire/20250812aq42418/fda-approves-brinsupri-brensocatib-as-the-first-and-only-treatment-for-non-cystic-fibrosis-bronchiectasis-a-serious-chronic-lung-disease