US-based biopharmaceutical company Insmed Incorporated (Nasdaq: INSM) said on Tuesday that the European Commission has approved BRINSUPRI (brensocatib 25mg tablets) for patients with non-cystic fibrosis bronchiectasis aged 12 and older who have experienced at least two exacerbations in the past year.

Reviewed under the European Medicines Agency's accelerated assessment pathway, the therapy is the first approved treatment for this condition in the European Union.

Non-cystic fibrosis bronchiectasis is a chronic, progressive lung disease marked by permanently widened airways, persistent inflammation, infection and repeated exacerbations. An estimated 600,000 people in the EU are diagnosed, with a further two million potentially undiagnosed.

The approval is supported by data from the Phase 3 ASPEN and Phase 2 WILLOW studies, which showed reductions in exacerbation rates, improved time to first exacerbation, higher rates of patients remaining exacerbation-free and less decline in lung function compared with placebo. The most common adverse reactions included headache, hyperkeratosis, dermatitis, rash, upper respiratory tract infections and dry skin.

Insmed said the decision represents an important milestone for patients and clinicians and reflects the strength of the clinical data. While regulatory reviews for brensocatib remain ongoing in the UK and Japan, Insmed plans to work with EU authorities to enable patient access from early 2026.