By VETTAPHARMA reporter – Derek Roche: Insmed announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved BRINSUPRI (brensocatib) for the treatment of 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 for NCFB in Japan, providing a new treatment option for patients with a chronic and progressive lung disease that can lead to permanent lung damage and declining lung function.
BRINSUPRI is an oral, once-daily treatment and is approved in Japan at a 25-mg dose. With the Japanese approval, BRINSUPRI is now approved for NCFB in the United States, Europe and Japan.
The approval was based on results from the Phase 3 ASPEN study, in which brensocatib significantly reduced pulmonary exacerbations compared with placebo over 52 weeks. The study also demonstrated significant improvements in several key secondary endpoints, including time to first exacerbation and the proportion of patients remaining exacerbation-free during treatment.
Patients receiving brensocatib 25 mg also experienced significantly lower lung function decline at Week 52, measured by post-bronchodilator forced expiratory volume in 1 second (FEV1).
BRINSUPRI is a small-molecule, reversible inhibitor of dipeptidyl peptidase 1 (DPP1). By inhibiting DPP1, the therapy is designed to reduce activation of neutrophil serine proteases in neutrophils, which are key drivers of chronic airway inflammation in NCFB.
NCFB is characterized by permanent widening of the airways resulting from a cycle of infection, inflammation, lung tissue damage and impaired mucociliary function. Patients can experience recurrent exacerbations, chronic cough, excessive sputum production, shortness of breath and repeated respiratory infections.
The safety profile observed in ASPEN was generally consistent with previous clinical experience. Common treatment-emergent adverse events included COVID-19, nasopharyngitis, cough and headache.
The Japanese approval expands access to BRINSUPRI in another major market and strengthens Insmed’s position in developing treatments for bronchiectasis, an area with substantial unmet medical need.
Quick FAQs
1. What Is BRINSUPRI?
BRINSUPRI (brensocatib) is an oral, once-daily DPP1 inhibitor designed to reduce neutrophil-driven airway inflammation.
2. What Happened?
Japan’s MHLW approved BRINSUPRI for adults and pediatric patients aged 12 years and older with non-cystic fibrosis bronchiectasis.
3. What Study Supported The Approval?
The approval was based on the Phase 3 ASPEN study.
4. What Were The Key Results?
Brensocatib significantly reduced pulmonary exacerbations, prolonged time to first exacerbation, increased the proportion of patients remaining exacerbation-free and reduced lung function decline at Week 52.
5. What Is The Mechanism Of Action?
BRINSUPRI reversibly inhibits DPP1, reducing activation of neutrophil serine proteases involved in chronic airway inflammation.
6. Why Is This Important?
BRINSUPRI is the first and only treatment approved by Japan’s MHLW for NCFB, providing a new treatment option for patients with a chronic disease that can cause permanent lung damage.
