FDA Approves BRINSUPRI as First Treatment for Non-Cystic Fibrosis Bronchiectasis.

Insmed's BRINSUPRI (brensocatib) has been approved by the FDA as the first treatment for non-cystic fibrosis bronchiectasis, a serious chronic lung disease affecting approximately 500,000 US patients. BRINSUPRI, a first-in-class DPP1 inhibitor targeting neutrophilic inflammation, is available by prescription through a comprehensive specialty pharmacy network. Insmed will host an investor conference call today at 12:00 PM ET.

Insmed Incorporated (Nasdaq: INSM) has achieved a significant milestone with the FDA approval of BRINSUPRI™ (brensocatib), the first and only treatment for non-cystic fibrosis bronchiectasis (NCFB) in adults and children 12 years and older. This approval marks a historic moment in respiratory medicine, addressing a critical gap in the treatment landscape for NCFB, a condition affecting approximately 500,000 diagnosed patients in the U.S. alone [1].

The approval is supported by robust clinical data from the Phase 3 ASPEN and Phase 2 WILLOW studies, which demonstrated significant clinical benefits. BRINSUPRI™ showed a 21.1% reduction in annual exacerbation rates at 10mg and 19.4% at 25mg compared to placebo. Both dosages also extended the time to first exacerbation and increased the proportion of patients remaining exacerbation-free [1].

What sets BRINSUPRI™ apart is its novel mechanism of action. By inhibiting dipeptidyl peptidase 1 (DPP1), it prevents the activation of neutrophil serine proteases, key drivers of chronic inflammation underpinning NCFB. This represents a shift from symptom management to addressing a root cause of disease progression [1].

The approval creates a substantial commercial opportunity for Insmed, as no competitive products exist. With patent protection likely extending well into the next decade, BRINSUPRI™ enters as both first and best-in-class. The company's established specialty pharmacy distribution network suggests thorough preparation for commercialization [1].

Looking ahead, 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 U.S. market [1].

Insmed will host an investor conference call today at 12:00 PM ET to discuss the FDA approval. The call can be accessed by dialing (888) 210-2654 (U.S. and Canada) or (646) 960-0278 (international) and entering the conference ID number 6364918. The call will also be webcast live on the Company's website at www.insmed.com [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