---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-25-042598"
form_type: "8-K"
ticker: "INSM"
cik: "0001104506"
company_name: "INSMED Inc"
filed_at: "2025-11-18T23:59:59+00:00"
generated_at: "2026-05-16T18:42:02.429221+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# European Commission approves BRINSUPRI as first treatment for NCFB in EU

## Summary
- 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).

## SEC filing metadata
- accession: 0001140361-25-042598
- form_type: 8-K
- ticker: INSM
- cik: 0001104506
- company_name: INSMED Inc
- filed_at: 2025-11-18T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1104506/000114036125042598/0001140361-25-042598-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1104506/000114036125042598/ef20059077_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-25-042598
- JSON: https://secwatch.observer/filing/0001140361-25-042598.json
- Plain text: https://secwatch.observer/filing/0001140361-25-042598.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.