Insmed’s Brinsupri Approved in Japan to Treat NCFB, Joining US and Europe

Editor’s Take: Expansion of the oral, once-daily treatment’s approval affects patients potentially as young as 12.

Insmed’s Brinsupri (brensocatib) gained approval from Japan’s Ministry of Health, Labour, and Welfare (MHLW) as an oral, once-daily treatment. Brinsupri treats non-cystic fibrosis bronchiectasis (NCFB) in adults and child patients 12 years and older.

Japan Gains NCFB Treatment

Brinsupri is the first and only MHLW-approved treatment for NCFB. It is also cleared, for the same indication and in the same age groups, in the United States and Europe.

NCFB is a chronic, progressive inflammatory lung disease that can lead to permanent lung damage and lung function decline. It causes airways to become forever widened through a cycle of infection, inflammation, lung tissue damage, and mucociliary dysfunction.

Symptoms include chronic cough, excessive sputum production, trouble breathing, fatigue, and repeated respiratory infections. These repeated exacerbations have often, in the past, required antibiotic therapy and/or hospital stays.

Conversely, approval for Brinsupri in Japan followed results of a Phase III trial showing brensocatib’s significant reduction of pulmonary exacerbations. In this study, brensocatib also showed significantly lower lung function decline after one year.

Insmed Execs Speak

“[The Japan approval] represents a profound milestone for people living with bronchiectasis,” Martina Flammer, MD, Insmed Chief Medical Officer, said. “Patients have faced a relentless cycle of exacerbations and declining lung function, with available care largely limited to symptom management. This approval reflects the contributions of patients and researchers who made this clinical evidence possible. [It also reflects] Insmed’s enduring commitment to developing therapies that address significant unmet needs in respiratory diseases, including bronchiectasis care.”

“Recurrent exacerbations represent a substantial disease burden, making daily life harder to manage,” Makoto Nakamura, Insmed SVP/General Manager, Japan, said. “By targeting key drivers of chronic airway inflammation, Brinsupri offers a new treatment option for appropriate patients in Japan. We’re proud of this important milestone and look forward to continuing to support the bronchiectasis community as we advance innovation.”