Shots:
The EC has approved Rhapsido (Remibrutinib) for the treatment of adults with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment
Approval was supported by P-III (REMIX-1 & 2) trials (n=925) in CSU pts, where remibrutinib showed superior improvements in itch, hives & weekly urticaria activity at Wk.12 vs PBO in pts uncontrolled on H1-antihistamines, with a favorable safety profile…
Shots:
The US FDA has approved Dupixent to treat CSU pts (≥12yrs.), who were symptomatic despite H1 antihistamine treatment based on 2 P-III (Study A & C) trials from LIBERTY-CUPID program; regulatory review ongoing in EU & other regions
Study A & C assessed Dupixent (loading dose then 300mg Q2W; pts weighing <60kg received 200mg)…

