#None #Insmed #Bronchiectasis #Brinsupri

European Commission Approves BRINSUPRI® as the First and Only Approved Treatment for Non-Cystic Fibrosis Bronchiectasis in the EU

On November 18, 2025, Insmed Incorporated (Nasdaq: INSM), a biopharmaceutical company dedicated to improving patient lives, announced that the European Commission has granted approval for BRINSUPRI® (brensocatib 25 mg), marking a significant milestone for those suffering from non-cystic fibrosis bronchiectasis (NCFB). This decision makes BRINSUPRI the first and only treatment approved for NCFB in the European Union, a chronic lung condition characterized by the permanent widening of airways, which can lead to severe health complications.

Understanding Non-Cystic Fibrosis Bronchiectasis

NCFB can result in irreversible lung damage, significantly affecting patients' quality of life. The disorder is characterized by frequent exacerbations, where symptoms such as cough, increased mucus, and breathlessness worsen considerably. Current estimates suggest around 600,000 individuals are diagnosed with NCFB in the EU, with millions more potentially remaining undiagnosed. Thus, the approval of BRINSUPRI is profoundly significant for those affected.

James Chalmers, MBChB, Ph.D., a key investigator in the ASPEN study, expressed that living with NCFB heavily influences daily activities and emotional well-being. He emphasized that the European Commission's approval is not merely a regulatory milestone; it is a beacon of hope for patients enduring this debilitating disease. BRINSUPRI aims to alleviate exacerbations and prevent disease progression, fundamentally altering the treatment landscape.

Clinical Trials and Efficacy

The approval of BRINSUPRI came after extensive scientific evaluation, including data from the Phase 3 ASPEN and Phase 2 WILLOW studies. In these studies, brensocatib demonstrated a 19.4% reduction in the annual rate of exacerbations compared to placebo. Furthermore, patients taking brensocatib enjoyed prolonged periods without exacerbations and experienced significantly less decline in lung function over a year of treatment.

In terms of safety, common side effects reported in trials included headaches, skin disorders, and upper respiratory infections, but further monitoring will inform ongoing assessments as the drug enters the market.

Insmed's Commitment and Future Plans

Martina Flammer, M.D., MBA, Chief Medical Officer of Insmed, highlighted the company's mission to serve underrepresented patient communities with innovative treatments. BRINSUPRI's approval is a step towards addressing the substantial unmet medical needs of patients suffering from NCFB, historically overlooked by the pharmaceutical industry.

Insmed plans to engage with health authorities across Europe to ensure timely access to BRINSUPRI for eligible patients starting in early 2026. The company is also pursuing regulatory approvals in other regions, including Japan and the UK, to expand the reach of this essential therapy.

Conclusion

The approval of BRINSUPRI underscores the importance of innovative therapies in transforming the management of chronic diseases. With this new treatment option, patients with non-cystic fibrosis bronchiectasis have a promising pathway to better manage their condition and improve their quality of life. As Insmed continues its focus on unmet medical needs, the healthcare community remains hopeful for future advancements and more effective solutions against debilitating diseases.