European Commission Approves BRINSUPRI™ as First Treatment for Non-Cystic Fibrosis Bronchiectasis

European Commission Approves BRINSUPRI™ for NCFB

On November 18, 2025, Insmed Incorporated announced a significant milestone in the treatment of non-cystic fibrosis bronchiectasis (NCFB) as the European Commission granted approval for BRINSUPRI™ (brensocatib). This approval marks the first and only therapy for NCFB in the European Union, designed for patients aged 12 and older who have experienced two or more exacerbations in the past year. This groundbreaking medication offers hope to a population often overshadowed by other respiratory conditions.

Understanding NCFB

NCFB is a chronic and progressive lung disease characterized by the permanent widening of the airways, making it challenging to clear mucus and bacteria. As a result, patients may encounter persistent inflammation and frequent exacerbations that significantly impact their quality of life. Symptoms typically include coughing, increased mucus production, shortness of breath, and fatigue. In the EU alone, about 600,000 individuals are diagnosed with this ailment, with a potential two million more undiagnosed, highlighting the urgent need for effective treatments.

The Role of BRINSUPRI

BRINSUPRI is classified as a first-in-class DPP1 inhibitor that targets neutrophilic inflammation, a key player in the disease's progression. The European Medicines Agency (EMA) acknowledged the medication under its accelerated assessment pathway due to its potential public health significance. The approval was heavily based on results from the Phase 3 ASPEN and Phase 2 WILLOW clinical trials, which demonstrated the compound's efficacy in reducing the rate of exacerbations and improving patients' lung function over time.

In the ASPEN study, patients treated with BRINSUPRI experienced a 19.4% reduction in the annual rate of exacerbations compared to those receiving a placebo. Furthermore, the drug significantly improved several secondary endpoints related to exacerbations, such as prolonging the time until the first exacerbation and increasing the number of patients remaining exacerbation-free. After 52 weeks, patients treated with BRINSUPRI exhibited a marked decrease in lung function decline, which is vital for managing this debilitating condition.

Safety Profile and Considerations

While introducing BRINSUPRI into treatment regimes presents numerous benefits, safety concerns were also assessed in the referenced studies. The most common adverse reactions included headaches, skin conditions, and respiratory infections, which were manageable and deemed acceptable against the potential benefits of the therapy. Insmed emphasizes the importance of regular monitoring for patients on this treatment to mitigate any dermatologic or dental complications.

Martina Flammer, Chief Medical Officer of Insmed, expressed the company's dedication to enhancing treatment options for this underserved group, stating, "With BRINSUPRI, we now have the first treatment for non-cystic fibrosis bronchiectasis approved in the European Union—a historically overlooked population with long-standing unmet medical needs."

Future Directions

As the company prepares to launch BRINSUPRI, it will seek to engage with health authorities to ensure that eligible patients gain access to this critical therapy by early 2026. Current evaluations are underway in the UK and Japan for brensocatib, further extending hope for many affected by NCFB globally.

In conclusion, BRINSUPRI represents a pivotal advancement in the fight against non-cystic fibrosis bronchiectasis, providing patients with a much-needed therapeutic option following years of unmet medical needs. This approval not only transforms patient care in the EU but also sets a precedent for further research and development in similar chronic lung diseases.