Japan’s Ministry of Health, Labour and Welfare has granted approval for Insmed Incorporated’s BRINSUPRI (brensocatib 25-mg tablet), marking the first approved therapy for non-cystic fibrosis bronchiectasis in the country.
BRINSUPRI is an oral, once-daily treatment designed for adults and pediatric patients aged 12 and older. The approval follows positive results from the 52-week phase 3 ASPEN study, which demonstrated that brensocatib reduced pulmonary exacerbations compared with placebo. The therapy also met secondary endpoints, including prolonging the time to first exacerbation and increasing the proportion of patients remaining exacerbation-free.
Patients treated with the 25 mg dose showed lower lung function decline at week 52, as measured by post-bronchodilator forced expiratory volume in one second. The most common treatment-emergent adverse events reported in at least 5.0% of patients included COVID-19, nasopharyngitis, cough, and headache.
BRINSUPRI is already approved in the United States and Europe, where it is available in both 10 mg and 25 mg tablet formulations. Insmed, headquartered in Bridgewater, New Jersey, specializes in developing therapies for rare diseases.
