Shots:
- The EC has approved Brinsupri (25mg) for treating NCFB pts (≥12yrs.), with ≥2 exacerbations in the prior 12mos. under EMA’saccelerated assessment pathway; Application is under PMDA & MHRA review, & Insmed is planning to work with EU authorities to enable patient access starting in early 2026
- Approval was based on extensive clinical data, incl. P-III (ASPEN) trial (n=1721) & P-II (WILLOW) trial (n=256) assessing Brinsupri (10 or 25mg, PO) vs PBO in NCFB pts for 52 & 24wks., respectively
- In ASPEN, Brinsupri (25mg) reduced annual exacerbations by 19.4%, showing benefits across exacerbation-related 2EPs with delayed first exacerbation & increased exacerbation-free pts; pts dosed with 25mg showed lower lung function decline per FEV₁ at wk. 52
Ref: Insmed| Image: Insmed| Press Release
Related News:- Insmed’s Brinsupri (Brensocatib) Receives the CHMP’s Positive Opinion to Treat Non-Cystic Fibrosis Bronchiectasis (NCFB)
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