Insmed Incorporated announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Brinsupri (brensocatib 25 mg tablets), a once-daily oral treatment for Non-Cystic Fibrosis Bronchiectasis (NCFB) in adults and pediatric patients aged 12 years and older.

The approval makes Brinsupri the first and only MHLW-approved treatment specifically for NCFB in Japan, providing patients and healthcare professionals with a new therapeutic option for managing the chronic and progressive respiratory disease. With the latest regulatory decision, Brinsupri is now approved in the United States, Europe and Japan.

NCFB is a chronic inflammatory lung disease in which the airways become permanently widened as a result of recurring infection, inflammation, lung tissue damage and impaired mucociliary function. Patients can experience repeated pulmonary exacerbations, chronic cough, excessive sputum production, shortness of breath and fatigue. Recurrent exacerbations can require antibiotic treatment or hospitalisation and may contribute to progressive lung function decline.

The Japanese approval is based on results from the Phase 3 ASPEN study, which evaluated the efficacy and safety of brensocatib over a 52-week treatment period. The study demonstrated that brensocatib significantly reduced pulmonary exacerbations compared with placebo and met several key secondary endpoints.

Patients receiving brensocatib also experienced a significantly longer time to their first exacerbation and a higher proportion remained exacerbation-free during the treatment period. Treatment with the 25 mg dose was additionally associated with significantly lower lung function decline at week 52, measured using post-bronchodilator forced expiratory volume in one second.

Brensocatib was generally well tolerated in the ASPEN study. The most frequently reported treatment-emergent adverse events occurring in at least 5 percent of patients included COVID-19, nasopharyngitis, cough and headache.

Martina Flammer, Chief Medical Officer, Insmed, said, “Today’s approval of Brinsupri represents a profound milestone for people living with bronchiectasis in Japan. She noted that people with the disease have faced a recurring cycle of exacerbations and declining lung function, while treatment has largely focused on symptom management.

Makoto Nakamura, Senior Vice President and General Manager, Japan, Insmed, said the approval provides an additional treatment option for appropriate patients by targeting key drivers of chronic airway inflammation.

Brinsupri contains brensocatib, a small-molecule, once-daily oral and reversible inhibitor of dipeptidyl peptidase 1 (DPP1). By inhibiting DPP1, the medicine is designed to prevent the activation of neutrophil serine proteases, enzymes that play an important role in chronic airway inflammation associated with NCFB.

The treatment is already approved in the United States for NCFB in adults and pediatric patients aged 12 years and older. In the European Union and United Kingdom, Brinsupri 25 mg is approved for patients aged 12 years and older with NCFB who have experienced two or more exacerbations in the preceding 12 months.

The Japanese approval further expands Insmed’s presence in the bronchiectasis treatment landscape and provides patients with NCFB access to a targeted therapy aimed at reducing exacerbations and slowing disease progression.