Novartis Presented Results of Remibrutinib (LOU064) in P-IIb Study for the Treatment of Chronic Spontaneous Urticaria at EADV

Shots:

• The P-IIb study evaluates the efficacy & safety of remibrutinib vs PBO in 311 patients with CSU inadequately controlled by H1-antihistamines for 12wks.
• The results showed an improvement in UAS7 related to CFB @4 & 12wks. & rapid improvement as of 1wks., patients achieved UAS7=0 (complete absence of hives & itch) and UAS7≤6 (well-controlled disease activity), favorable safety profile & good tolerability across all doses with no dose-dependent pattern. The therapy showed significant dose-response related to CFB in UAS7 score @4wks.
• Remibrutinib is a highly selective, potent BTK inhibitor. The company is expected to start P-III studies of remibrutinib in CSU at the end of 2021

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