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BRINSUPRI® (brensocatib) Approved by Japan's Ministry of Health, Labour and Welfare for the Treatment of Patients With Non-Cystic Fibrosis Bronchiectasis, a Serious, Chronic Lung Disease

  • Japan's Ministry of Health, Labour and Welfare approved BRINSUPRI (brensocatib 25-mg tablet) as the first-in-disease & first-in-class therapy for non-cystic fibrosis bronchiectasis (NCFB) in adults & pediatric patients 12 years & older.
  • The approval is based on Phase 3 ASPEN study results showing brensocatib significantly reduced pulmonary exacerbations, prolonged time to first exacerbation, increased exacerbation-free patients, & slowed lung function decline (FEV1) over 52 weeks.
  • BRINSUPRI is now approved for NCFB treatment in the U.S., Europe, & Japan, providing an option to manage this progressive disease that can cause permanent lung damage.
  • Common treatment-emergent adverse events occurring in at least 5.0% of patients included COVID-19, nasopharyngitis, cough, & headache.
  • Important safety warnings include increased risks of dermatologic reactions (rash, dry skin, hyperkeratosis), gingival & periodontal adverse reactions, & potential liver function test elevations.
  • Use of live attenuated vaccines is advised against during BRINSUPRI treatment due to unknown safety & effectiveness impacts.
  • Safety & effectiveness in pediatric patients younger than 12 years of age have not been established.
  • Insmed Incorporated is a Bridgewater, N.J.-based biopharmaceutical company advancing therapies for serious diseases across Respiratory, Immunology & Inflammation, & Neuro & Other Rare therapeutic areas.