Insmed Receives Japan Approval for BRINSUPRI in Bronchiectasis

Insmed Incorporated has received regulatory approval from Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for BRINSUPRI (brensocatib) for the treatment of bronchiectasis in adult patients.

This approval marks a significant milestone for Insmed as it expands the global reach of BRINSUPRI, its first-in-class dipeptidyl peptidase 1 (DPP1) inhibitor. Bronchiectasis is a chronic lung condition characterized by abnormal widening of the bronchi, leading to mucus buildup and recurrent infections.

The PMDA decision follows the positive data from the ASPEN clinical trial program, which demonstrated that brensocatib significantly reduced the rate of pulmonary exacerbations compared to placebo in patients with bronchiectasis.

Japan represents a meaningful market opportunity for BRINSUPRI, given the recognized prevalence of bronchiectasis in the Asia-Pacific region. Insmed has stated it will work to ensure patient access to the therapy in Japan as quickly as possible following this approval.

BRINSUPRI had previously received approval in the United States and other markets, and the Japan approval further solidifies its position as a global treatment option for this underserved patient population.