Insmed Incorporated (NASDAQ: INSM) has announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for brensocatib, a potential treatment for patients with non-cystic fibrosis bronchiectasis. The FDA has granted priority review to the NDA and set a target action date of August 12, 2025, under the Prescription Drug User Fee Act (PDUFA). The FDA has not indicated whether an advisory committee will be convened to discuss the application.
The NDA is based on data from the landmark Phase 3 ASPEN study, where both dosage strengths of brensocatib achieved statistical and clinical significance for the reduction in the annualized rate of pulmonary exacerbations versus placebo over the 52-week treatment period. Patients treated with brensocatib 25 mg also showed significantly lower lung function decline at week 52 as measured by post-bronchodilator forced expiratory volume over one second.
Regarding safety, brensocatib was well-tolerated in the study, with treatment-emergent adverse events occurring in at least 5.0% of patients treated with either dose of brensocatib and more frequently than in placebo. These adverse events included COVID-19, nasopharyngitis, cough, and headache.
Insmed plans to file regulatory submissions for brensocatib in the EU, UK, and Japan in 2025, with commercial launches anticipated in 2026, pending approval in each territory. The company also highlighted that bronchiectasis is a chronic, progressive disease with no approved treatments, leaving hundreds of thousands of people in the U.S. without an effective way to reduce the pulmonary exacerbations that can lead to serious consequences.
Brensocatib is a small molecule, oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1) being developed by Insmed for the treatment of patients with bronchiectasis, chronic rhinosinusitis without nasal polyps, hidradenitis suppurativa, and other neutrophil-mediated diseases.
Insmed Incorporated is a global biopharmaceutical company focused on delivering first and best-in-class therapies to transform the lives of patients facing serious diseases. The company is advancing a diverse portfolio of approved and mid to late-stage investigational medicines, with its most advanced programs in pulmonary and inflammatory conditions. The company's early-stage research programs encompass a wide range of technologies and modalities, including gene therapy, AI-driven protein engineering, protein manufacturing, RNA end-joining, and synthetic rescue. Following these announcements, the company's shares moved -0.5%, and are now trading at a price of $81.06. For more information, read the company's full 8-K submission here.
