Novartis Rhapsido® (remibrutinib) receives FDA approval as first treatment for symptomatic dermographism (SD), expanding its use beyond chronic spontaneous urticaria (CSU)

What happened: The FDA approved Novartis Rhapsido (remibrutinib) as the first treatment for adults with symptomatic dermographism (SD) not controlled by H1 antihistamines, expanding its approved use beyond chronic spontaneous urticaria (CSU). Key numbers: At Week 12, 29.3% of Rhapsido patients achieved complete hive response vs 14.0% with placebo (p=0.0229), with responses as early as Week 2. Why it matters: Rhapsido becomes the only prescription treatment approved for both CSU and SD, and the approval highlights the potential of BTK inhibition across immune-mediated diseases.

The FDA approved Novartis Rhapsido (remibrutinib) as the first treatment for adults with symptomatic dermographism (SD) not controlled by H1 antihistamines, expanding its approved use beyond chronic spontaneous urticaria (CSU).

Rhapsido becomes the only prescription treatment approved for both CSU and SD, and the approval highlights the potential of BTK inhibition across immune-mediated diseases.