Insmed's NDA for Lung Disease Drug Gets FDA's Priority Review

Core Viewpoint - Insmed Incorporated has received FDA acceptance for its new drug application for brensocatib, a reversible inhibitor of dipeptidyl peptidase 1 (DPP1), aimed at treating non-cystic fibrosis bronchiectasis, with a decision expected by August 12, 2025 [1][2]. Company Developments - If approved, brensocatib will be the first and only treatment for bronchiectasis, a chronic lung disease currently lacking approved therapies, and the first DPP1 inhibitor for neutrophil-mediated diseases [2]. - Insmed plans to launch brensocatib in the U.S. in Q3 2025, following the expected approval [2]. - The NDA is based on data from the phase III ASPEN study, which demonstrated significant reductions in pulmonary exacerbations with both 10mg and 25mg doses of brensocatib compared to placebo [3][4]. Clinical Study Insights - The ASPEN study met its primary endpoint, showing both doses of brensocatib achieved statistically significant reductions in the annualized rate of pulmonary exacerbations [4]. - Secondary endpoints were also met, including prolonged time to first pulmonary exacerbation and increased odds of remaining exacerbation-free over a 52-week treatment period [4]. Future Plans - Insmed intends to submit regulatory filings for brensocatib in the UK, EU, and Japan in 2025, with a potential launch in 2026 for these territories [5]. - Additionally, brensocatib is being evaluated in the phase IIb BiRCh study for chronic rhinosinusitis without nasal polyps, with top-line data expected by the end of 2025 [6]. Market Performance - Over the past year, Insmed's shares have increased by 182.7%, contrasting with a 6.5% decline in the industry [3].