Insmed(US:INSM) Prnewswireยท2025-02-06 13:00Core Viewpoint - Insmed Incorporated's brensocatib has received FDA acceptance for New Drug Application (NDA) for treating non-cystic fibrosis bronchiectasis, potentially becoming the first approved treatment for this condition and the first DPP1 inhibitor if approved [1][2] Group 1: FDA Review and Approval Process - The FDA has granted Priority Review to the NDA with a target action date of August 12, 2025, under the Prescription Drug User Fee Act (PDUFA) [1] - The FDA has previously granted brensocatib Breakthrough Therapy Designation, indicating its potential for significant improvement in treating serious conditions [4] Group 2: Clinical Study Results - The NDA is based on the Phase 3 ASPEN study, which demonstrated statistical and clinical significance in reducing the annualized rate of pulmonary exacerbations over a 52-week treatment period [2][6] - Both dosage strengths of brensocatib met several prespecified exacerbation-related secondary endpoints, including prolonging time to first exacerbation and increasing odds of remaining exacerbation-free [2] Group 3: Patient Population and Market Potential - Approximately 500,000 patients in the U.S., 600,000 in the EU5, and 150,000 in Japan are diagnosed with bronchiectasis, with no approved therapies currently available in these regions [7][8] - Insmed plans to file regulatory submissions for brensocatib in the EU, UK, and Japan in 2025, with commercial launches anticipated in 2026, pending approval [5] Group 4: Safety and Tolerability - Brensocatib was well-tolerated in the study, with treatment-emergent adverse events occurring in at least 5.0% of patients, including COVID-19 (15.8% for 10 mg, 20.9% for 25 mg), nasopharyngitis (7.7% for 10 mg), cough (7.0% for 10 mg), and headache (6.7% for 10 mg) [3]