FDA Approves Remibrutinib for Symptomatic Dermographism

The FDA recently approved remibrutinib (Rhapsido; Novartis), an oral Bruton's tyrosine kinase inhibitor (BTKi), as the first treatment for adults with symptomatic dermographism (SD) inadequately controlled by H1 antihistamines. The decision follows the first FDA approval of remibrutinib for chronic spontaneous urticaria (CSU) just over a year ago.¹

According to Novartis, more than 50% of patients with SD remain symptomatic despite H1 antihistamines. Remibrutinib is now the only prescription treatment with approved uses in both CSU and SD when antihistamines alone do not control symptoms. The company identifies SD as the most prevalent type of chronic inducible urticaria.¹

The approval is based on the SD cohort of the phase 3 RemIND clinical trial (NCT05976243), which included patients remaining symptomatic on second-generation H1 antihistamines. Remibrutinib demonstrated higher rates of complete response from hives vs placebo, as measured by the Total Fric Score.¹

At week 12, 29.3% of patients treated with remibrutinib achieved complete response from hives vs 14.0% with placebo (P = .0229).¹ Responses were observed as early as week 2, according to Novartis.¹

Giselle Mosnaim, MD, MS, an allergist and immunologist at Endeavor Health, clinical professor at the University of Chicago Pritzker School of Medicine, and lead RemIND investigator, said in the news release, "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."¹

Remibrutinib Safety Profile and Tolerability in Symptomatic Dermographism

Through week 24 of clinical trials, remibrutinib demonstrated a consistent safety profile in SD and CSU, according to Novartis. The most common adverse events (incidence ≥3%) were nasopharyngitis (nasal congestion, sore throat, and runny nose), bleeding, headache, nausea, and abdominal pain. Novartis stated no routine laboratory monitoring is required.¹

RemIND also evaluated remibrutinib in additional forms of chronic inducible urticaria, including cold urticaria and cholinergic urticaria. Novartis plans to submit the full RemIND data set to health authorities globally, where appropriate.¹

Novartis also reported no liver safety signals in the phase 3 REMODEL-1 (NCT05147220) and REMODEL-2 (NCT05156281) trials of remibrutinib in relapsing multiple sclerosis, consistent with the CSU experience.¹ Those trials compared remibrutinib with teriflunomide and showed a clinically meaningful reduction in annualized relapse rates and a clinically meaningful delay in disability progression, with a favorable safety profile, according to the company.¹

Lindsey Finklea, MD, a dermatologist, adjunct professor at the University of Texas at San Antonio, and RemIND investigator, said in the news release, "Having the first FDA-approved medicine specifically for SD marks an important change in how clinicians can approach care and offers renewed hope for patients whose symptoms are not adequately controlled by H1 antihistamines."¹

Novartis reported more than 90% of adults with chronic hives have CSU or SD, making remibrutinib the only treatment indicated for both of the 2 most common forms. Remibrutinib is also approved for CSU in the EU, UK, and China.¹

In the phase 3 REMIX-1 (NCT05030311) and REMIX-2 (NCT05032157) trials of patients with CSU, remibrutinib reduced the urticaria activity score over 7 days vs placebo at week 12 (least squares mean change, −20.0 vs −13.8 in REMIX-1 and −19.4 vs −11.7 in REMIX-2; P < .001 for both).² Remibrutinib continues to be studied in hidradenitis suppurativa and food allergy.¹

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/news/media-releases/novartis-rhapsido-remibrutinib-receives-fda-approval-first-treatment-symptomatic-dermographism-sd-expanding-its-use-beyond-chronic-spontaneous-urticaria-csu
2. Metz M, Giménez-Arnau A, Hide M, et al. Remibrutinib in chronic spontaneous urticaria. N Engl J Med. 2025;392(10):984-994. doi:10.1056/NEJMoa2408792