The U.S. Food and Drug Administration (FDA) has approved BRINSUPRI™ (brensocatib), making it the first and only therapy for non-cystic fibrosis bronchiectasis (NCFB).
This chronic lung disease affects more than 500,000 people in the United States and has long been without an approved treatment option.
What is Non-Cystic Fibrosis Bronchiectasis?
Non-cystic fibrosis bronchiectasis is a serious and progressive airway disease. It occurs when the airways, or bronchi, become permanently widened due to repeated cycles of infection and inflammation. The widened airways trap mucus, which then promotes further bacterial growth and worsening infections.
Symptoms of the condition include:
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Persistent coughing that produces large amounts of mucus
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Shortness of breath during activity or even at rest
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Fatigue that limits daily tasks
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Repeated chest infections requiring antibiotics or hospitalization
Over time, these repeated flare-ups damage the lung tissue permanently, leading to progressive loss of lung function. Unlike asthma or chronic obstructive pulmonary disease (COPD), there was no approved medicine designed specifically to stop or slow this cycle — until now.
How BRINSUPRI Works
BRINSUPRI is a first-in-class, once-daily oral therapy available in 10 mg and 25 mg doses. It works by blocking an enzyme called dipeptidyl peptidase 1 (DPP1). DPP1 activates neutrophil serine proteases — enzymes in white blood cells that, while essential for fighting infections, also cause chronic lung inflammation when present in excess.
By stopping DPP1 activity, BRINSUPRI reduces neutrophil-driven inflammation in the lungs. This helps prevent the destructive cycle of infection, inflammation, and tissue damage. Experts say it is the first therapy to directly address the root biological process behind bronchiectasis, instead of only managing symptoms.
Clinical Trial Evidence that Supported FDA Approval
The FDA’s decision was based on results from the ASPEN Phase 3 trial, the largest clinical study ever conducted for bronchiectasis. More than 1,700 patients across 35 countries, including both adults and adolescents, took part.
Key results included:
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Patients on BRINSUPRI had up to a 21% reduction in annualized pulmonary exacerbations compared to placebo.
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Both 10 mg and 25 mg doses significantly delayed the time to first exacerbation, meaning patients stayed stable longer.
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Nearly half of all patients on BRINSUPRI remained free of flare-ups at 52 weeks, compared to only 40% of patients on placebo.
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The 25 mg dose helped preserve lung function, reducing the typical decline in forced expiratory volume (FEV1) that patients normally face.
Additional subgroup analyses showed the medicine was effective across diverse populations, including adolescents, people already on maintenance macrolide antibiotics, and patients with different levels of blood eosinophils.
Expert and Patient Reactions
Doctors and patient advocates hailed the approval as a historic milestone.
“This approval represents a complete change in how we treat non-cystic fibrosis bronchiectasis,” said Dr. Doreen Addrizzo-Harris, Professor of Pulmonary, Critical Care and Sleep Medicine at NYU Grossman School of Medicine.
“For the first time, we have a therapy that targets the underlying inflammation instead of just treating symptoms. Based on trial results, this could become the standard of care for patients.”
Patient advocates also stressed the importance of the decision. Elisha Malanga, Executive Director of the Bronchiectasis and NTM Association, noted, “Living with bronchiectasis means frequent flare-ups that disrupt daily life and cause anxiety about long-term health.
The FDA approval of brensocatib is a long-awaited breakthrough that gives patients new hope for better control over their condition.”
What are the impacts of BRINSUPRI on the pharmaceutical industry?
Establishing the First DPP1 Inhibitor as a Marketed Therapy
The approval of BRINSUPRI marks the first time a dipeptidyl peptidase 1 (DPP1) inhibitor has entered the market. This is important because it validates a completely new drug class aimed at controlling neutrophil-driven inflammation, a pathway involved in many chronic respiratory and autoimmune diseases.
It signals confidence that therapies working on unique immune targets can move from theory to clinical practice.
Expanding Treatment Models Beyond Symptom Management
Historically, therapies for bronchiectasis and similar respiratory conditions focused on reducing symptoms or treating infections once they appeared. BRINSUPRI changes this model by targeting the underlying inflammatory mechanism that causes disease progression.
This approach may inspire more pharmaceutical companies to design drugs that go deeper into the biology of chronic diseases rather than managing only the visible effects.
Opening Research Opportunities in Other Neutrophil-Mediated Conditions
Because BRINSUPRI successfully demonstrated clinical benefit in bronchiectasis, it paves the way for testing the same mechanism in other conditions where neutrophil activity drives damage. Insmed is already investigating brensocatib in chronic rhinosinusitis without nasal polyps and hidradenitis suppurativa.
Strengthening the Business Case for Respiratory and Inflammation Research
Pharmaceutical companies often face challenges when investing in respiratory diseases due to high costs and uncertain returns.
The success of BRINSUPRI shows that with the right mechanism and evidence, breakthroughs are possible even in conditions that had no approved therapy for decades. This approval may encourage renewed funding and collaborations in the respiratory and inflammation pipeline.
Commercial Growth and Market Differentiation for Insmed
For Insmed, this approval secures a first-mover advantage in a large, underserved market with more than 500,000 patients in the United States alone. With global filings under review in Europe, the UK, and Japan, the company is positioned to capture strong market demand.
Analysts suggest that the commercial success of BRINSUPRI could transform Insmed from a mid-sized biopharma into a recognized global leader in specialty respiratory care.
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