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)…
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…

