Insmed Incorporated (NASDAQ: INSM) has just announced that the European Commission has approved Brinsupri™ (brensocatib 25 mg tablets) for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in patients aged 12 and older with two or more exacerbations in the previous 12 months. This approval marks a significant milestone as Brinsupri is the first and only treatment approved for NCFB in the European Union.
The approval was based on a comprehensive 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, patients who received Brinsupri 25 mg experienced a statistically significant less 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 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 made this milestone possible, emphasizing the company's mission to bring new therapies to underserved patient communities.
This approval follows a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) on October 16, 2025, and Insmed will engage with authorities across the EU to secure access to Brinsupri for eligible patients beginning in early 2026.
Brinsupri is a small molecule, once-daily, oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1) and is also indicated in the United States for the treatment of NCFB in adult and pediatric patients 12 years of age or older.
Insmed is committed to delivering first and best-in-class therapies to transform the lives of patients facing serious diseases and is focused on advancing a diverse portfolio of approved and mid to late-stage investigational medicines, particularly in pulmonary and inflammatory conditions. Following these announcements, the company's shares moved 2.83%, and are now trading at a price of $202.98. If you want to know more, read the company's complete 8-K report here.
