Shots:The CHMP has recommended Brinsupri (Brensocatib) for treating NCFB pts (≥12yrs.) with two or more exacerbations in the prior 12 mos.Opinion 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…
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 approvalsApproval was based on P-III (ASPEN) trial (n=1721) & P-II (WILLOW) trial…

