WASHINGTON (dpa-AFX) - Monday, Insmed Inc. (INSM) announced that Japan's Ministry of Health, Labour and Welfare has approved BRINSUPRI, or brensocatib 25-mg tablet, for the treatment of non-cystic fibrosis bronchiectasis, a chronic, progressive, and inflammatory lung disease.
With this approval, the oral, once-daily treatment is now approved for use in the U.S., Europe, and Japan in adults and pediatric patients aged 12 years and older.
This approval is backed by results from the Phase 3 ASPEN study, which demonstrated that brensocatib significantly reduced pulmonary exacerbations compared with placebo over the treatment period.
The 52-week study also met multiple key secondary endpoints, including significantly prolonging the time to first exacerbation and significantly increasing the proportion of patients remaining exacerbation-free over the treatment period.
In addition to this, patients treated with brensocatib 25 mg demonstrated significantly lower lung function decline at week 52, as measured by post bronchodilator forced expiratory volume in 1 second.
In pre-market hours, INSM is trading at $125.03, down 0.59 percent on the Nasdaq.
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