Shots:
- The US FDA has approved Brinsupri (10 & 25mg) for treating NCFB pts (≥12yrs.); it is now available in the US. MAA is under EMA & MHRA review with a Japan filing planned in 2025 & potential launches in 2026 pending approvals
- Approval was based on 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, with WILLOW enrolling pts who had ≥2 documented pulmonary exacerbations in 12mos. prior to screening
- In ASPEN, Brinsupri (10 & 25mg) reduced annual exacerbations by 21.1% & 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
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