Insmed wins Japan approval for BRINSUPRI
- Insmed received approval from Japan’s Ministry of Health, Labour and Welfare for BRINSUPRI (brensocatib) to treat non-cystic fibrosis bronchiectasis.
- BRINSUPRI is now approved in the United States, Europe, and Japan for eligible patients.
- Insmed stated that approval was supported by Phase 3 ASPEN study results showing reduced pulmonary exacerbations compared with placebo.
Insmed (NASDAQ:INSM) announced that Japan’s Ministry of Health, Labour and Welfare approved BRINSUPRI (brensocatib 25 mg) for adults and pediatric patients aged 12 years and older with non-cystic fibrosis bronchiectasis.
The approval makes BRINSUPRI the first and only treatment approved for non-cystic fibrosis bronchiectasis in Japan, according to Insmed, and follows regulatory authorizations in the United States and Europe.
The approval was based on the Phase 3 ASPEN study, where brensocatib reduced pulmonary exacerbations compared with placebo over 52 weeks, extended time to first exacerbation, and increased the proportion of patients without exacerbations.
Insmed stated that BRINSUPRI was generally well tolerated in clinical studies.
The company reported that common adverse events associated with brensocatib included COVID-19, nasopharyngitis, cough, and headache, while the ASPEN study also showed lower lung function decline measured by FEV1.
Insmed develops therapies for serious and rare diseases, with BRINSUPRI focused on addressing inflammation-related processes involved in non-cystic fibrosis bronchiectasis.
