European Commission approves BRINSUPRI as first treatment for NCFB in EU

INSMED Inc

EC approved BRINSUPRI (brensocatib 25 mg) for NCFB patients 12+ years with ≥2 exacerbations in prior 12 months.
First and only approved treatment for non-cystic fibrosis bronchiectasis in the EU; reviewed under accelerated assessment.
Phase 3 ASPEN study showed 19.4% reduction in annual exacerbation rate vs placebo; key secondary endpoints met.
Approval follows positive CHMP opinion on 16 Oct 2025; Insmed plans EU access starting early 2026.
Applications also under review in UK (MHRA) and Japan (PMDA).

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