• 19 Nov 2025
• Admin
• News Article

BRINSUPRI: EU Approves First-Ever Treatment for Non-Cystic Fibrosis Bronchiectasis

The European Commission has approved BRINSUPRI (brensocatib 25 mg) as the first approved treatment for non-cystic fibrosis bronchiectasis (NCFB). The decision follows an accelerated assessment by the EMA, reflecting the therapy’s high public-health importance.

This marks a major milestone for patients who have long faced a chronic, progressive disease with no approved treatments.

Why the Approval Matters

NCFB Is a Serious, Long-Ignored Respiratory Condition

NCFB causes:

• Permanently widened airways
• Impaired mucus clearance
• Persistent infection and inflammation
• Repeated exacerbations that worsen lung damage

Patients often deal with chronic cough, excess sputum, shortness of breath, fatigue, and frequent respiratory infections.

About 600,000 people in the EU are diagnosed with NCFB, and up to two million more remain undiagnosed.

BRINSUPRI: A First-in-Class DPP1 Inhibitor

BRINSUPRI is a first-in-disease, first-in-class inhibitor of DPP1, a key enzyme involved in activating neutrophil serine proteases. These enzymes drive the neutrophilic inflammation central to NCFB progression.

Key facts:

• Once-daily oral tablet
• Approved for patients 12 years and older
• For individuals with two or more exacerbations in the prior 12 months

This is the first time EU patients have access to a therapy that targets the underlying inflammatory pathway of the disease.

What the Clinical Evidence Shows

The approval is based on the Phase 3 ASPEN study and Phase 2 WILLOW study, both published in the New England Journal of Medicine.

ASPEN (Phase 3) Highlights

• 19.4% reduction in annual exacerbation rate vs placebo
• Longer time to first exacerbation
• More patients remained exacerbation-free over 52 weeks
• Less decline in lung function, measured by FEV₁ after bronchodilator

Most common side effects:

• Headache
• Hyperkeratosis
• Dermatitis and rash
• Upper respiratory infections
• Dry skin

WILLOW (Phase 2) Highlights

• Evaluated once-daily brensocatib for 24 weeks
• Measured time to first pulmonary exacerbation
• Enrolled adults with ≥2 exacerbations in the prior year

Both trials show brensocatib can reduce flares, protect lung function, and address the cycle of inflammation that drives the disease.

What Experts Are Saying

A Critical Moment for Patients

“This approval offers a much-needed therapy that reduces exacerbations and may slow progression,”
— James Chalmers, MBChB, PhD, University of Dundee

A Milestone for an Underserved Population

“Brensocatib becomes the first treatment for a historically overlooked population,”
— Martina Flammer, M.D., MBA, Chief Medical Officer, Insmed

What Happens Next?

• Insmed will work with EU member states to secure patient access starting early 2026.
• Applications are under review in the UK and Japan.

How BRINSUPRI Works?

BRINSUPRI inhibits DPP1, which activates neutrophil serine proteases—enzymes that fuel chronic airway inflammation in NCFB.

The goal:

• Reduce destructive inflammation
• Break the infection–inflammation–damage cycle
• Prevent long-term decline

The therapy is also being studied in other diseases where neutrophils play a key role.

About Insmed

Insmed is a global biopharma company focused on serious, underserved diseases.
Its portfolio includes:

• Approved medicines for chronic lung conditions
• Mid- and late-stage programs in pulmonary and inflammatory diseases
• Early-stage work in gene therapy, protein engineering, synthetic rescue, and RNA-based technologies

Fast Summary (for quick readers)

• What happened? EU approved BRINSUPRI, the first-ever treatment for NCFB.
• Why it matters? NCFB has no approved treatments and affects hundreds of thousands.
• How does it work? A first-in-class DPP1 inhibitor that reduces neutrophilic inflammation.
• What did trials show? Fewer exacerbations, slower lung decline, and strong safety data.
• What’s next? EU access in 2026; reviews ongoing in the UK and Japan.