FDA Approves First Symptomatic Dermographism Treatment

The FDA approved remibrutinib (Rhapsido; Novartis) today, October 7, 2026, as the first treatment for adults with symptomatic dermographism (SD) inadequately controlled by H1 antihistamines.¹

With today’s approval, remibrutinib, an oral, highly selective Bruton tyrosine kinase (BTK) inhibitor, became the only prescription treatment with approved uses in both chronic spontaneous urticaria (CSU) and SD. It received approval to treat patients with CSU who remain symptomatic despite treatment with H1 antihistamine therapy on September 30, 2025.²

SD is a common skin condition in which light pressure, rubbing, or scratching on the skin causes raised, red, itchy hives to form within minutes.³ Remibrutinib blocks the BTK pathway involved in the release of histamine, a key driver of hives and swelling.¹

“For the SD community, the approval of remibrutinib represents important progress,” Kristen Willard, executive director of We CU, a global community supporting people with chronic urticaria, said in a news release. “People living with this condition deserve treatment options developed specifically for this condition, and we are hopeful about what this milestone means for the community.”

Remibrutinib Demonstrates Efficacy, Consistent Safety in SD

The decision was based on data from the SD cohort of the phase 3 RemIND trial (NCT05976243), in which investigators analyzed patients who remained symptomatic despite treatment with second-generation H1 antihistamines.⁴ They found that remibrutinib demonstrated higher rates of complete response from hives vs placebo, as measured by the Total Fric Score.¹ At week 12, significantly more patients treated with remibrutinib achieved a complete response from hives compared with placebo (29.35% vs 14.0%; P = .0229), with responses seen as early as week 2.

Through week 24, remibrutinib demonstrated a consistent safety profile in both SD and CSU. The most common adverse events included nasal congestion, sore throat, runny nose, bleeding, headache, nausea, and abdominal pain.

“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,” Giselle Mosnaim, MD, MS, lead RemIND trial investigator, clinical professor at the University of Chicago Pritzker School of Medicine, and allergist and immunologist at Endeavor Health, said in a news release.

Remibrutinib Advances Across Immune-Mediated Conditions

The RemIND study also evaluated remibrutinib in additional forms of chronic inducible urticaria, including cold and cholinergic urticaria, as Novartis plans to submit the full RemIND dataset to health authorities globally where appropriate. In addition, remibrutinib continues to be studied in other immune-mediated conditions, including food allergy and hidradenitis suppurativa.

Separately, Novartis recently announced positive topline results from the phase 3 REMODEL-1 (NCT05147220) and REMODEL-2 (NCT05156281) trials in relapsing multiple sclerosis (MS). The results demonstrated a clinically meaningful reduction in annualized relapse rates and a clinically meaningful delay in disability progression with remibrutinib vs teriflunomide (Aubagio; Sanofi). Consistent with findings in CSU, patients with relapsing MS who took remibrutinib had a favorable safety profile and no liver safety signals.

“With Rhapsido now approved for the 2 most common forms of chronic hives, more people may have the opportunity to find relief from persistent itch, regain confidence in their daily lives, and focus less on their symptoms and more on the moments that matter,” Victor Bultó, US president of Novartis, said in a news release. “We are proud to advance the science of BTK inhibition as we work to bring new treatment options to patients with unmet needs across immunology and beyond.”

References

1. 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 7, 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
2. McNulty R. FDA approves remibrutinib for chronic spontaneous urticaria. AJMC^®. September 30, 2025. Accessed October 7, 2026. https://www.ajmc.com/view/fda-approves-remibrutinib-for-chronic-spontaneous-urticaria
3. Dermographism. DermNet. Accessed October 7, 2026. https://dermnetnz.org/topics/dermographism
4. A study to investigate efficacy, safety, and tolerability of remibrutinib compared with placebo in adults with CINDU inadequately controlled by H1-antihistamines. ClinicalTrials.gov. Updated August 20, 2026. Accessed October 7, 2026. https://clinicaltrials.gov/study/NCT05976243