Insmed Incorporated (Nasdaq: INSM) announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved Brinsupri (brensocatib 25-mg tablet), an oral, once-daily treatment for non-cystic fibrosis bronchiectasis (NCFB) in adults and pediatric patients 12 years and older.

The approval, based on results from the Phase 3 ASPEN study, makes Brinsupri the first MHLW-approved treatment for NCFB. The drug is now approved in the U.S., Europe, and Japan.

In the ASPEN study, brensocatib significantly reduced pulmonary exacerbations compared with placebo over a 52-week treatment period. The study also met multiple key secondary endpoints, including significantly prolonging the time to first exacerbation and increasing the proportion of patients remaining exacerbation-free. Patients treated with brensocatib 25 mg showed significantly 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 in at least 5% of patients were COVID-19, nasopharyngitis, cough, and headache.

NCFB is a chronic, progressive inflammatory lung disease that causes airways to become permanently widened due to recurring cycles of infection, inflammation, and tissue damage. Patients frequently experience repeated exacerbations requiring antibiotic therapy or hospitalization.

"Patients have long faced a relentless cycle of exacerbations and declining lung function, with available care largely limited to symptom management," said Martina Flammer, M.D., MBA, Chief Medical Officer of Insmed.

Brinsupri is a small molecule, reversible inhibitor of dipeptidyl peptidase 1 (DPP1), designed to inhibit the activation of neutrophil serine proteases that drive chronic airway inflammation in NCFB. In the U.S., the drug is approved in 10-mg and 25-mg formulations. In the European Union and United Kingdom, the 25-mg tablet is approved for patients with two or more exacerbations in the prior 12 months.