FDA Approves Novartis’ Rhapsido as First Treatment Specifically for Symptomatic Dermographism

The U.S. Food and Drug Administration (FDA) has granted approval for Novartis’ Rhapsido (remibrutinib) as the first FDA-approved treatment specifically designed for adults with symptomatic dermographism (SD) whose condition is inadequately controlled by H1 antihistamines.

Key Highlights of the Approval and Clinical Trial

Expanded Indication: The approval builds on Rhapsido’s previous indication for chronic spontaneous urticaria (CSU), making it the only prescription treatment approved in the U.S. for the two most common forms of chronic hives when H1 antihistamines fall short.
Clinical Efficacy: Based on the Phase III RemIND trial, Rhapsido achieved a statistically significant complete response rate in hive resolution (29.3% at Week 12) compared to placebo (14.0%), with visible responses as early as Week 2.
Mechanism & Safety: Rhapsido is an oral, highly selective Bruton’s tyrosine kinase (BTK) inhibitor that blocks the histamine-releasing BTK pathway. It demonstrated a consistent safety profile without the requirement of routine laboratory monitoring.
Broader Pipeline: Novartis is continuing to study remibrutinib across other immune-mediated conditions, including multiple sclerosis, food allergies, and hidradenitis suppurativa.