Insmed Announces that FDA Does Not Currently Plan to Hold Advisory Committee Meeting to Discuss New Drug Application for Brensocatib in Patients with Bronchiectasis

Core Viewpoint - The FDA has reaffirmed that Insmed's New Drug Application (NDA) for brensocatib is under Priority Review, with a target action date set for August 12, 2025, indicating a significant step towards potential approval for treating bronchiectasis [1][2]. Company Overview - Insmed Incorporated is a global biopharmaceutical company focused on developing first- and best-in-class therapies for serious diseases, with a diverse portfolio of approved and investigational medicines [5][6]. - The company is recognized as one of the best employers in the biopharmaceutical industry, having been named the No. 1 Science Top Employer for four consecutive years [6]. Product Information - Brensocatib is an investigational small molecule, oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1), aimed at treating bronchiectasis and other neutrophil-mediated diseases [4]. - The NDA for brensocatib is based on data from the ASPEN study, the largest Phase 3 study conducted in patients with bronchiectasis, which highlights its potential to be the first approved treatment for this condition [2][4]. Disease Context - Bronchiectasis is a chronic lung disease affecting approximately 500,000 patients in the U.S., 600,000 in the EU5, and 150,000 in Japan, with no approved therapies specifically targeting the disease in these regions [3]. - The disease is characterized by permanent dilation of the bronchi due to infection and inflammation, leading to symptoms such as chronic cough and shortness of breath [3].