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2d ago

FDA Approves Brensocatib as First Treatment for Non-Cystic Fibrosis Bronchiectasis

Insmed plans 2026 launches across key markets with an $88,000 annual list price following FDA clearance.

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo
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Around 500,000 people in the US are estimated to have NCFB, according to Insmed. Credit: HobbitArt via Shutterstock.com.

Overview

  • Brensocatib, marketed as Brinsupri, is approved for adults and children 12 years and older based on WILLOW and ASPEN trials that showed 19–21% reductions in pulmonary exacerbation rates and extended time to first flare-up.
  • The drug is the first on-label dipeptidyl peptidase-1 inhibitor for non-CF bronchiectasis, targeting neutrophil-driven inflammation to address the root cause of recurrent lung infections.
  • FDA labeling highlights common adverse reactions such as upper respiratory infections, gingival and periodontal events, dermatologic reactions and hypertension, and includes precautions on live vaccines.
  • Insmed has set a US list price of $88,000 per year for Brinsupri and expects net pricing to be 25–35% lower after rebates and discounts.
  • Applications have been filed or accepted in Europe and the UK, with a planned Japan submission, and analysts forecast peak annual sales of $5–6 billion for the therapy.