Insmed Incorporated (NASDAQ: INSM) has announced the European Commission's approval of Brinsupri (Brensocatib 25 mg tablets) for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in patients 12 years of age and older with two or more exacerbations in the prior 12 months. This marks a significant milestone as it becomes the first and only approved treatment indicated for NCFB in the European Union (EU).
The approval was based on a comprehensive scientific evaluation of the marketing authorization application, including data from the Phase 3 ASPEN and Phase 2 WILLOW studies. In the ASPEN study, patients taking Brinsupri 25 mg experienced a 19.4% reduction in the annual rate of exacerbations compared to placebo. Additionally, Brinsupri 25 mg also 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 decline in lung function, as measured by forced expiratory volume in one second (FEV₁) after using a bronchodilator at week 52. The safety of Brinsupri was also evaluated in both studies, with the most frequently reported adverse reactions being headache (9.2%), hyperkeratosis (5.9%), dermatitis (4.2%), rash (4.1%), upper respiratory tract infections (3.9%), and dry skin (3.0%).
Insmed's Chief Medical Officer, Martina Flammer, M.D., MBA, expressed gratitude to the patients, clinicians, and partners who contributed to this milestone. The company's mission has always been to bring new therapies to underserved patient communities, and with Brinsupri, they aim to address the long-standing unmet medical needs of the NCFB population.
The approval in the EU follows a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) on October 16, 2025. Insmed will be engaging with authorities across the EU to secure access to Brinsupri for eligible patients beginning in early 2026. Additionally, applications for Brensocatib are currently under review with the Medicines and Healthcare Products Regulatory Agency in the U.K. and the Pharmaceuticals and Medical Devices Agency in Japan.
Brinsupri (Brensocatib) is a small molecule, once-daily, oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1). It is designed to inhibit the activation of enzymes in neutrophils that are key drivers of chronic airway inflammation in NCFB. The approval of Brinsupri in the EU represents a significant advancement in addressing the unmet medical needs of patients with NCFB, a chronic and progressive disease that can lead to permanent lung damage and decline in lung function. As a result of these announcements, the company's shares have moved 2.14% on the market, and are now trading at a price of $201.62. For more information, read the company's full 8-K submission here.
