01—Abstract
Summary
Summary of the 8-K filed November 18, 2025. Cited figures are marked; the original filing is the authoritative source.
On November 18, 2025, Insmed Incorporated (Nasdaq: INSM) filed a Form 8-K under Items 7.01 (Regulation FD Disclosure) and 8.01 (Other Events) to report that the European Commission has approved BRINSUPRI (brensocatib 25 mg tablets) for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in patients 12 years of age and older with two or more exacerbations in the prior 12 months.
The approval follows a positive opinion from the EMA's Committee for Medicinal Products for Human Use on October 16, 2025, and the drug was reviewed under the EMA's accelerated assessment pathway. The company says it will engage with EU authorities to secure access for eligible patients beginning in early 2026. Brensocatib is also under review with the UK's MHRA and Japan's PMDA.
The press release (Exhibit 99.1) describes the Phase 3 ASPEN study, in which patients taking BRINSUPRI 25 mg had a 19.4%a reduction in annual rate of exacerbations versus placebo, along with statistically significant less decline in FEV1 at week 52. The most frequently reported adverse reactions were headache (9.2%), hyperkeratosis (5.9%), dermatitis (4.2%), rash (4.1%), upper respiratory tract infections (3.9%), and dry skin (3.0%). The company states the EU approval is the first and only approved treatment for NCFB in the EU.
For investors, the filing is a regulatory milestone that expands BRINSUPRI's approved geography beyond the United States. The filing does not provide sales guidance or commercial financial figures. The release notes that the EU indication is narrower than the U.S. indication, which covers adult and pediatric patients 12 years and older without the two-exacerbation requirement.
02—Key points
Key Highlights
- European Commission approved BRINSUPRI (brensocatib 25 mg tablets) for NCFB in patients aged 12 and older with two or more exacerbations in the prior 12 months
- Approval follows a positive CHMP opinion from the EMA on October 16, 2025, and was granted under accelerated assessment
- Company describes BRINSUPRI as the first and only approved treatment for NCFB in the European Union
- In the Phase 3 ASPEN study, BRINSUPRI 25 mg produced a 19.4% reduction in annual rate of exacerbations versus placebo
- Most frequent adverse reactions include headache (9.2%), hyperkeratosis (5.9%), dermatitis (4.2%), and rash (4.1%)
- Insmed plans to secure access for eligible EU patients beginning in early 2026; UK and Japan applications remain under review
- The EU indication is narrower than the U.S. indication, which is not limited by exacerbation history
03—Questions
Frequently Asked Questions
What did the European Commission approve?
The EC approved BRINSUPRI (brensocatib 25 mg tablets) for treating non-cystic fibrosis bronchiectasis in patients 12 years of age and older with two or more exacerbations in the prior 12 months.
When will EU patients have access to BRINSUPRI?
Insmed says it will engage with authorities across the EU to secure access for eligible patients beginning in early 2026.
What efficacy data supported the approval?
The approval relied on the Phase 3 ASPEN study and Phase 2 WILLOW study. In ASPEN, patients taking BRINSUPRI 25 mg had a 19.4% reduction in annual rate of exacerbations compared with placebo, and showed statistically significant less decline in FEV1 at week 52.
What are the most common side effects?
The most frequently reported adverse reactions were headache (9.2%), hyperkeratosis (5.9%), dermatitis (4.2%), rash (4.1%), upper respiratory tract infections (3.9%), and dry skin (3.0%). The U.S. label also includes warnings for dermatologic and gingival/periodontal adverse reactions and advises avoiding live attenuated vaccines.
Are there other regulatory reviews pending?
Applications for brensocatib are under review with the UK's Medicines and Healthcare products Regulatory Agency and Japan's Pharmaceuticals and Medical Devices Agency.
04—Continue