Insmed Reports Positive Topline Results From ASPEN Study Of Brensocatib; Plans To File NDA

(RTTNews) - Insmed (INSM) announced positive topline results from the ASPEN study, a randomized, double-blind, placebo-controlled Phase 3 study to assess the efficacy, safety, and tolerability of brensocatib in patients with non-cystic fibrosis bronchiectasis. The study met its primary endpoint, with both dosage strengths of brensocatib demonstrating statistically significant reductions in the annualized rate of pulmonary exacerbations versus placebo. The study also met several of its prespecified secondary endpoints.

Based on the results, Insmed plans to file a New Drug Application with the FDA for brensocatib in patients with bronchiectasis in the fourth quarter of 2024. Pending approvals, Insmed anticipates a U.S. launch for brensocatib in mid-2025 followed by launches in Europe and Japan in the first half of 2026.

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