The European Commission has approved Insmed’s BRINSUPRI (brensocatib 25 mg tablets) as the first and only authorized treatment for non-cystic fibrosis bronchiectasis (NCFB) in the European Union. The therapy is approved for patients aged 12 and older who experienced at least two exacerbations in the previous year. BRINSUPRI was granted accelerated assessment by the European Medicines Agency due to its significant public health value.
NCFB is a chronic, progressive lung disease in which the airways become permanently widened, impairing mucus clearance and increasing susceptibility to infection and inflammation. The condition leads to frequent exacerbations marked by worsening cough, increased mucus production, shortness of breath, and fatigue. An estimated 600,000 people in the EU have been diagnosed with NCFB, while an additional two million may remain undiagnosed.
The approval is supported by data from the Phase 3 ASPEN trial and Phase 2 WILLOW trial, both published in the New England Journal of Medicine. In ASPEN, patients receiving BRINSUPRI 25 mg experienced a 19.4% reduction in the annual rate of exacerbations compared with placebo. The drug also met key secondary endpoints, including delaying the time to first exacerbation, increasing the proportion of patients who remained exacerbation-free, and reducing lung function decline over 52 weeks.
Safety data from both studies showed the most common adverse reactions included headache, hyperkeratosis, dermatitis, rash, upper respiratory tract infections, and dry skin.
Clinical experts welcomed the approval as a turning point for a disease long lacking targeted treatment options. “This marks a major milestone for patients and clinicians,” said ASPEN lead investigator Professor James Chalmers of the University of Dundee, noting the therapy’s potential to reduce flares and slow disease progression.
Insmed’s Chief Medical Officer Dr. Martina Flammer highlighted the significance of addressing an “overlooked population with long-standing unmet medical needs,” adding that BRINSUPRI could become the new standard of care for patients with a history of repeated exacerbations.
The European Commission’s decision follows a positive recommendation from the EMA’s Committee for Medicinal Products for Human Use. Insmed plans to work with EU member states to enable patient access beginning in early 2026. Regulatory reviews for brensocatib are ongoing in the U.K. and Japan.