Japan’s Ministry of Health, Labour and Welfare has approved BRINSUPRI (brensocatib 25 mg tablets) for the treatment of non-cystic fibrosis bronchiectasis in adults and pediatric patients aged 12 years or older, the first therapy cleared for this condition in the country.
BRINSUPRI, an oral once-daily therapy, is a reversible inhibitor of dipeptidyl peptidase 1 designed to reduce chronic airway inflammation by inhibiting neutrophil enzyme activation. The approval follows positive results from the Phase 3 ASPEN study, which demonstrated a reduction in pulmonary exacerbations over a 52-week treatment period compared with placebo.
The trial also met multiple secondary endpoints, including prolonging the time to first exacerbation and increasing the proportion of patients remaining exacerbation-free. Patients receiving the 25 mg dose showed a lower decline in lung function at week 52, as measured by post-bronchodilator forced expiratory volume in one second.
The most frequently reported treatment-emergent adverse events—occurring in at least 5.0% of patients—were COVID-19, nasopharyngitis, cough, and headache. The drug is now approved in the United States, Europe, and Japan, with U.S. formulations available in 10 mg and 25 mg tablets for the same patient population.
Insmed Incorporated, based in Bridgewater, New Jersey, markets BRINSUPRI globally. Non-cystic fibrosis bronchiectasis is a chronic, progressive lung disease characterized by permanent airway enlargement due to recurrent infections, inflammation, and lung tissue damage, often requiring antibiotic therapy or hospitalization.
