Japan Approves BRINSUPRI (brensocatib) as First-in-Class Treatment for Non-Cystic Fibrosis Bronchiectasis
核心洞察
Japan's Ministry of Health, Labour and Welfare (MHLW) approved BRINSUPRI (brensocatib 25-mg tablet), an oral, once-daily treatment for non-cystic fibrosis bronchiectasis (搜索) (NCFB) in adults and pediatric patients 12 years and older.
BRINSUPRI is the first and only MHLW-approved therapy for NCFB, and with this approval it is now available in the U.S., Europe, and Japan.
Approval was based on the Phase 3 ASPEN study, which showed brensocatib significantly reduced pulmonary exacerbations versus placebo and slowed lung function decline over 52 weeks.
Japan's Ministry of Health, Labour and Welfare (MHLW) has approved BRINSUPRI (brensocatib 25-mg tablet), an oral, once-daily treatment for non-cystic fibrosis bronchiectasis (搜索) (NCFB) in adults and pediatric patients 12 years and older, Insmed Incorporated announced on August 24, 2026. The approval marks the first and only MHLW-approved therapy for NCFB, a chronic and progressive disease that can lead to permanent lung damage and lung function decline. With this decision, BRINSUPRI is now approved for use in the United States, Europe, and Japan.
"Today's approval of BRINSUPRI represents a profound milestone for people living with bronchiectasis in Japan," said Martina Flammer, M.D., MBA, Chief Medical Officer of Insmed. "Patients have long faced a relentless cycle of exacerbations and declining lung function, with available care largely limited to symptom management. This approval reflects the contributions of patients and researchers who made this clinical evidence possible, as well as Insmed's enduring commitment to developing therapies that address significant unmet needs in respiratory diseases, including bronchiectasis care."
Clinical Evidence from the Phase 3 ASPEN Study
The MHLW approval is based on results from the Phase 3 ASPEN study, which demonstrated that brensocatib significantly reduced pulmonary exacerbations compared with placebo over the 52-week treatment period. The study also met multiple key secondary endpoints, including significantly prolonging the time to first exacerbation and significantly increasing the proportion of patients remaining exacerbation-free over the treatment period.
Patients treated with brensocatib 25 mg also demonstrated significantly lower lung function decline at week 52, as measured by post-bronchodilator forced expiratory volume in 1 second (FEV1), a standard measure of lung function. Brensocatib was generally well tolerated in the study. The most common treatment-emergent adverse events (TEAEs) occurring in at least 5.0% of patients were COVID-19, nasopharyngitis, cough, and headache.
Mechanism of Action
BRINSUPRI (brensocatib) is a small molecule, once-daily, oral, reversible inhibitor of dipeptidyl peptidase 1 (搜索) (DPP1). It is designed to inhibit the activation of enzymes known as neutrophil serine proteases in neutrophils, which are key drivers of chronic airway inflammation in NCFB.
"In patients living with bronchiectasis, recurrent exacerbations represent a substantial disease burden, making daily life harder to manage and affecting long-term clinical outcomes," said Makoto Nakamura, Senior Vice President, General Manager, Japan for Insmed. "By targeting key drivers of chronic airway inflammation, BRINSUPRI offers a new treatment option for appropriate patients in Japan."
Disease Background and Unmet Need
Non-cystic fibrosis bronchiectasis (搜索) (NCFB) is a chronic, progressive, and inflammatory lung disease that causes the airways to become permanently widened due to a cycle of infection, inflammation, lung tissue damage, and mucociliary dysfunction. Patients with NCFB often experience repeated exacerbations, requiring antibiotic therapy and/or hospitalizations. Symptoms include chronic cough, excessive sputum production, shortness of breath, fatigue, and repeated respiratory infections, which can worsen the underlying disease.
Safety Profile
In the ASPEN trial, the most common adverse reactions (≥2%) included upper respiratory tract infection, headache, rash, dry skin, hyperkeratosis, and hypertension. The safety profile for adult patients with NCFB in the WILLOW study was generally similar to ASPEN, except for a higher incidence of gingival and periodontal adverse reactions.
Treatment with BRINSUPRI is associated with an increase in dermatologic adverse reactions, including rash, dry skin, and hyperkeratosis, as well as an increase in gingival and periodontal adverse reactions. The use of live attenuated vaccines should be avoided in patients receiving BRINSUPRI. In ASPEN, there was an increase from baseline in average ALT, AST, and alkaline phosphatase levels at all time points from Week 4 through Week 56 in both BRINSUPRI 10 mg and 25 mg arms compared to placebo. The incidence of skin cancers among patients treated with BRINSUPRI 10 mg and 25 mg was 0.5% and 1.9%, respectively, compared to 1.1% in placebo-treated patients.
Global Regulatory Status
BRINSUPRI is approved in the United States as brensocatib 10 mg and 25 mg tablets for the treatment of NCFB in adult and pediatric patients 12 years of age or older. In the European Union and United Kingdom, BRINSUPRI (brensocatib 25 mg tablets) is approved for the treatment of NCFB in patients 12 years of age and older with two or more exacerbations in the prior 12 months. In Japan, BRINSUPRI (brensocatib 25 mg tablets) is approved for the treatment of patients with NCFB in adult and pediatric patients 12 years and older.