FDA Approves Rhapsido as First Treatment for Symptomatic Dermographism in Adults

On October 7, 2026, the US Food and Drug Administration (FDA) approved remibrutinib (Rhapsido), an oral, highly selective Bruton’s tyrosine kinase inhibitor (BTKi), as the first treatment for adults with symptomatic dermographism (SD) inadequately controlled by H1 antihistamines. The approval expands the drug’s existing indication for adults with chronic spontaneous urticaria (CSU) inadequately controlled by H1 antihistamines.

With the new indication, remibrutinib is the only prescription treatment approved for both CSU and SD, the 2 most common forms of chronic hives.

The FDA approval is based on data from the SD cohort of the phase 3 RemIND trial, which evaluated patients who remained symptomatic despite treatment with second-generation H1 antihistamines. Efficacy was assessed using the Total Fric Score, with remibrutinib demonstrating higher rates of complete response from hives compared with placebo.

At week 12, the study demonstrated:
• 29.3% of patients receiving remibrutinib achieved a complete response from hives compared with 14.0% receiving placebo (P = .0229).
• Responses to remibrutinib were observed as early as week 2.

“SD is a chronic, debilitating condition with historically limited treatment options,” said Giselle Mosnaim, MD, MS, lead RemIND trial investigator. “Remibrutinib offers, for the first time, an approach to treatment specifically for SD patients who remain inadequately controlled with H1 antihistamines alone, representing a meaningful step forward for this population.”

Remibrutinib is a highly selective BTKi that blocks the BTK pathway involved in the release of histamine, a key driver of hives and swelling.

In clinical trials through week 24, remibrutinib demonstrated a consistent safety profile across SD and CSU. The most common adverse events, occurring at an incidence of at least 3%, were nasopharyngitis, bleeding, headache, nausea, and abdominal pain.

Remibrutinib may cause serious bleeding, with risk potentially increased among patients taking blood thinners. Clinicians may also consider temporarily discontinuing treatment for 3 to 7 days before and after planned medical or surgical procedures. Live or live-attenuated vaccines should not be administered during treatment.

“For people living with SD, seemingly routine contact with the skin can trigger hives and itch,” said Lindsey Finklea, MD, a RemIND trial investigator. “Having the first FDA-approved medicine specifically for SD marks an important change in how clinicians can approach care.”

Reference
Novartis Rhapsido (remibrutinib) receives FDA approval as first treatment for symptomatic dermographism (SD), expanding its use beyond chronic spontaneous urticaria (CSU). News release. Novartis. October 7, 2026. Accessed October 8, 2026. https://www.novartis.com/us-en/news/media-releases/novartis-rhapsido-remibrutinib-receives-fda-approval-first-treatment-symptomatic-dermographism-sd-expanding-its-use-beyond-chronic-spontaneous-urticaria-csu