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Investing.com -- Insmed Incorporated (NASDAQ:INSM) stock rose 6% Tuesday after the FDA approved BRINSUPRI (brensocatib), the first and only treatment for non-cystic fibrosis bronchiectasis (NCFB), a chronic lung disease affecting approximately 500,000 diagnosed patients in the U.S.
The approval represents a significant milestone for Insmed as BRINSUPRI becomes the first FDA-approved therapy specifically targeting NCFB, a progressive condition that can lead to permanent lung damage. The oral, once-daily treatment will be available in 10 mg and 25 mg doses for adults and children 12 years and older.
Clinical data supporting the approval showed that patients taking BRINSUPRI experienced a 21.1% reduction in annual exacerbation rates at the 10 mg dose and 19.4% at the 25 mg dose compared to placebo. The drug also significantly prolonged time to first exacerbation and increased the proportion of patients remaining exacerbation-free during the treatment period.
"This FDA approval represents a potential paradigm shift in how we approach non-cystic fibrosis bronchiectasis," said Doreen Addrizzo-Harris, M.D., FCCP, Professor at NYU Grossman School of Medicine and ASPEN investigator. "For the first time, we have a treatment that directly targets neutrophilic inflammation and addresses a root cause of bronchiectasis exacerbations. Based on the strength of the data and the impact we’ve seen in patients, I believe this could become the new standard in non-cystic fibrosis bronchiectasis care."
BRINSUPRI is a first-in-class dipeptidyl peptidase 1 (DPP1) inhibitor designed to reduce chronic airway inflammation. The company has also submitted applications with European regulators and plans to file in Japan in 2025, with potential commercial launches in these regions anticipated in 2026.
The drug is now available in the U.S. by prescription through specialty pharmacies.
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