Japan’s Ministry of Health, Labour and Welfare (MHLW) approved Insmed’s BRINSUPRI (brensocatib) for the treatment of non-cystic fibrosis bronchiectasis (NCFB).
The once-daily oral tablet is the first and only approved therapy for this chronic and progressive lung disease in Japan. Patients in the region previously relied on limited options focused primarily on symptom management.
The regulatory approval applies to both adults and pediatric patients aged 12 and older.
Data from the Phase 3 ASPEN study supported the decision. The trial demonstrated that brensocatib significantly reduced the frequency of pulmonary exacerbations compared to a placebo.
This expansion into the Japanese market follows previous regulatory approvals for the therapy in the United States and Europe.