Insmed Incorporated (NASDAQ: INSM) has announced the FDA approval of Brinsupri™ (Brensocatib) as the first and only treatment for non-cystic fibrosis bronchiectasis (NCFB). The approval represents a potential paradigm shift in the approach to NCFB, providing a treatment that directly targets neutrophilic inflammation and addresses a root cause of bronchiectasis exacerbations. Brinsupri 10 mg and 25 mg doses have been approved for the treatment of NCFB, marking a significant advancement for patients and clinicians across the U.S.
The approval is based on data from the phase 3 ASPEN and phase 2 WILLOW studies, both of which were published in the New England Journal of Medicine. In the ASPEN study, patients taking Brinsupri 10 mg or 25 mg experienced a 21.1% and 19.4% reduction in the annual rate of exacerbations, respectively, compared to placebo. Additionally, both dosage strengths of Brinsupri met several exacerbation-related secondary endpoints, including significantly prolonging the time to the first exacerbation and increasing the proportion of patients remaining exacerbation-free over the treatment period. Moreover, patients who received Brinsupri 25 mg experienced a statistically significant lesser decline in lung function, as measured by forced expiratory volume in one second (FEV1) after using a bronchodilator, at week 52.
The safety profile of Brinsupri was also evaluated in both studies, with the most common adverse reactions ≥2% in the ASPEN trial including upper respiratory tract infection, headache, rash, dry skin, hyperkeratosis, and hypertension. The safety profile for adult patients with NCFB in the WILLOW study was generally similar to ASPEN, except for a higher incidence of gingival and periodontal adverse reactions.
Brinsupri is a first-in-class dipeptidyl peptidase 1 (DPP1) inhibitor, designed to inhibit the activation of enzymes (neutrophil serine proteases) in neutrophils that are key drivers of chronic airway inflammation in NCFB. The company plans to file for approval in other territories, with commercial launches anticipated in 2026 pending approval.
Insmed is committed to providing access to its products by offering eligible patients financial assistance options through its inlighten patient support program. The company's advanced programs are focused on serving patient communities where the need is greatest, with a diverse portfolio of approved and mid* to late-stage investigational medicines. Insmed is headquartered in Bridgewater, New Jersey, with offices and research locations throughout the United States, Europe, and Japan.
This FDA approval marks a significant milestone for Insmed and for patients living with NCFB, offering a potential new standard in care for this chronic and progressive disease. As a result of these announcements, the company's shares have moved 6.12% on the market, and are now trading at a price of $119.80. Check out the company's full 8-K submission here.
