Imagine living with a lung condition that feels like your airways are stuck in an endless loop of infection and inflammation, robbing you of simple joys like deep breaths or carefree outings—yet hope is on the horizon with the EU's groundbreaking approval of a pioneering treatment for non-cystic fibrosis bronchiectasis (NCFB). This isn't just medical news; it's a lifeline for millions grappling with this often-overlooked progressive lung disease.
But here's where it gets controversial—could this new therapy revolutionize care, or are we overlooking potential downsides in our excitement? Let's dive into the details and explore what this means for patients and the broader medical community.
The European Commission has officially greenlit BRINSUPRI® (brensocatib), marking it as the inaugural and currently sole approved therapy for non-cystic fibrosis bronchiectasis across the European Union. This milestone comes as a beacon for those battling this severe, advancing lung ailment that can inflict irreversible damage on the lungs. BRINSUPRI stands out as a trailblazing DPP1 inhibitor—a type of medication designed to tame neutrophilic inflammation, which is a first-of-its-kind approach targeting the root causes of this condition.
To put it simply, DPP1 inhibitors work by blocking an enzyme that activates other enzymes in white blood cells called neutrophils, which play a big role in the chronic swelling and irritation seen in NCFB. Think of it like turning down the volume on an overactive immune response that's harming the lungs rather than healing them. And this is the part most people miss: BRINSUPRI underwent an accelerated review by the EMA because of its significant public health implications, fast-tracking its approval to address an urgent need.
Based in Bridgewater, New Jersey, Insmed Incorporated—a biopharmaceutical firm dedicated to prioritizing people and delivering life-changing treatments for serious illnesses—shared this exciting update. BRINSUPRI (brensocatib 25 mg tablets) is now authorized for adults and adolescents aged 12 and up who have experienced at least two flare-ups in the past year. It's the first-ever treatment specifically approved for NCFB in the EU, positioning it as a pioneering option in a field where options have been sorely lacking.
NCFB is a long-term, worsening respiratory illness that differs from conditions like asthma or COPD, where airways typically constrict. Instead, in bronchiectasis, the airways widen permanently, making it tougher to expel mucus and germs. This leads to ongoing swelling, infections, and a vicious cycle that can degrade lung health over time. Picture someone constantly coughing up thick mucus, feeling breathless, or battling fatigue—these are hallmarks of frequent exacerbations, or sudden worsening episodes, that can disrupt daily life and sometimes require hospitalization.
Estimates suggest around 600,000 individuals in the EU have been formally diagnosed with NCFB, but that's likely just the tip of the iceberg, with up to two million more potentially undiagnosed. For instance, someone mistaking persistent coughs for allergies might be overlooking this condition, delaying crucial care.
"Dealing with non-cystic fibrosis bronchiectasis turns everyday existence upside down, affecting not only your physical state but also your mental and emotional resilience," remarked Dr. James Chalmers, MBChB, Ph.D., a professor and respiratory specialist at the University of Dundee in the UK, who led the ASPEN study. "The European Commission's decision is a game-changer for European patients and doctors alike, introducing a vital option to cut down on exacerbations, possibly halt the disease's march forward, and fundamentally alter how we manage this incapacitating ailment."
This endorsement stems from rigorous scientific scrutiny, drawing on insights from the Phase 3 ASPEN trial and the Phase 2 WILLOW study, both featured in the prestigious New England Journal of Medicine. In the ASPEN trial, participants on brensocatib 25 mg saw a notable 19.4% drop in yearly exacerbation rates compared to those on placebo. Moreover, it successfully extended the time before the first flare-up and boosted the number of people who went through the entire period without any exacerbations. Lung function, measured by FEV1 after bronchodilator use, also declined less sharply in the brensocatib group at the 52-week mark.
Safety profiles from both trials were closely examined. Common side effects included headaches (9.2%), hyperkeratosis (5.9%), dermatitis (4.2%), rashes (4.1%), upper respiratory infections (3.9%), and dry skin (3.0%). While these are manageable for many, it raises an interesting debate: are these trade-offs worth it for the benefits, or could they deter some patients?
"At Insmed, our core purpose is to introduce innovative treatments for patient groups that have been underserved," stated Martina Flammer, M.D., MBA, Insmed's Chief Medical Officer. "With brensocatib, we've achieved the first EU approval for non-cystic fibrosis bronchiectasis treatment—a community long neglected with pressing unmet needs. The fast-tracked approval underscores the robustness of our evidence and its promise to set a new benchmark for care in those who've had at least two prior exacerbations. We're deeply thankful to the patients, healthcare providers, and collaborators who paved the way for this breakthrough."
Building on a favorable recommendation from the EMA's Committee for Medicinal Products for Human Use on October 16, 2025, Insmed plans to collaborate with EU regulators to ensure access for qualifying patients starting early in 2026.
Applications for brensocatib are also in progress with regulatory bodies in the UK and Japan, hinting at broader global implications.
For more in-depth resources on NCFB, check out Insmed's media page (accessible via this link for EU media only).
Media inquiries can be directed to Angelika Maerz, Director of Corporate Communications for EMEA, at +41 79 378 0247 or via email.
Notes for Editors
About BRINSUPRI (brensocatib)
BRINSUPRI (brensocatib) is a compact molecule formulated as a daily oral pill, acting as a reversible DPP1 inhibitor. In the EU, it's approved as brensocatib 25 mg tablets for treating NCFB in individuals aged 12 and older who've had two or more exacerbations in the last year.
The drug targets the activation of neutrophil serine proteases in neutrophils, key culprits behind the persistent airway inflammation in NCFB. It's also under investigation for other conditions driven by neutrophils.
Full EU product details will be available soon in the Summary of Product Characteristics (SmPC) on the EMA website.
About the ASPEN Trial
ASPEN was an international, randomized, double-blinded, placebo-controlled Phase 3 investigation evaluating brensocatib's effectiveness, safety, and tolerability in NCFB patients. It involved over 460 sites across nearly 40 nations, narrowing to 391 active locations in 35 countries after exclusions. Adults (18-85 years) were assigned in a 1:1:1 ratio, while adolescents (12 to under 18) followed a 2:2:1 split for 10 mg or 25 mg brensocatib or placebo daily over 52 weeks, plus a 4-week washout. The main analysis covered 1,680 adults and 41 teens.
About the WILLOW Trial
WILLOW was a randomized, double-blinded, placebo-controlled, multi-site, international Phase 2 study testing brensocatib's efficacy, safety, tolerability, and pharmacokinetics over 24 weeks in NCFB patients. Conducted at 116 locations, it included 256 adults with at least two prior exacerbations, randomized 1:1:1 to 10 mg or 25 mg brensocatib or placebo. The key goal was measuring time to first exacerbation versus placebo.
About Bronchiectasis
Non-cystic fibrosis bronchiectasis (NCFB) is a chronic, escalating inflammatory lung disorder causing permanent airway widening from repeated cycles of infection, swelling, tissue harm, and impaired mucus clearance. Patients frequently face recurring exacerbations, often needing antibiotics or hospital stays. Typical symptoms encompass persistent coughing, heavy mucus, breathlessness, tiredness, and frequent infections that compound the illness. As noted, about 600,000 in the EU are diagnosed, with potentially two million more undetected.
About Insmed
Insmed Incorporated is a global biopharmaceutical leader that puts people first, focusing on therapies to improve lives for those with grave conditions. Their diverse pipeline includes approved and advanced investigational drugs, plus innovative research in areas like gene therapy and AI-enhanced protein design. Specializing in pulmonary and inflammatory diseases, they offer two approved treatments for chronic lung issues. Headquartered in Bridgewater, New Jersey, with operations in the US, Europe, and Japan, Insmed has been named among the top employers in biopharma for five straight years.
What do you think—does this approval represent a true paradigm shift in treating NCFB, or are there aspects like side effects that make you question its widespread adoption? Share your thoughts in the comments below, and let's discuss whether prioritizing rapid access might sometimes come at the cost of long-term safety data. Agree or disagree? We'd love to hear!
