Remibrutinib Receives FDA Approval for Symptomatic Dermographism

The US Food and Drug Administration (FDA) has approved remibrutinib (Rhapsido) for adults with symptomatic dermographism (SD), the most common form of chronic inducible urticaria, inadequately controlled by H1 antihistamines, based on data from the phase 3 RemIND trial.¹ Novartis announced the approval expanding the therapy’s indication beyond chronic spontaneous urticaria (CSU) on October 7.

The decision makes remibrutinib, an oral Bruton tyrosine kinase (BTK) inhibitor, the first therapy approved specifically for SD and the only agent indicated for both SD and CSU, according to Novartis.¹ The FDA first approved remibrutinib for CSU in 2025 on the strength of the phase 3 REMIX-1 and REMIX-2 trials.^2,3 The SD indication uses the same 25 mg twice-daily oral dose.²

“SD is a chronic, debilitating condition with historically limited treatment options,” said Giselle Mosnaim, MD, MS, allergist and immunologist, Endeavor Health, and lead RemIND 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.”

What was Remibrutinib’s efficacy in the phase 3 RemIND trial?

RemIND was a 52-week, multicenter, randomized, double-blind, placebo-controlled trial (NCT05976243) enrolling 115 adults with SD for at least 4 months despite background H1 antihistamines.² Eligibility required a Total Fric Score (TFS) of 3 or higher (range, 0–4) on FricTest 4.0 and an itch numerical rating scale (NRS) score of 5 or higher after provocation.² Patients were randomized 1:1 to remibrutinib 25 mg or placebo twice daily for 24 weeks, followed by a 28-week open-label period on remibrutinib.²

Mean patient age was 39.2 years, 71.3% (82/115) of patients were female, and 58.3% (67/115) had a baseline TFS of 4.² Mean disease duration at enrollment was 5.8 years.²

At week 12, 29.3% (17/58) of patients receiving remibrutinib achieved a complete TFS response (TFS = 0), compared with 14.0% (8/57) receiving placebo (treatment difference, 15.0%; 95% CI, 0.3–29.7; P = .0229).^1,2 Improvements in TFS and itch NRS at week 12 were consistent regardless of baseline total IgE level, according to the label.²

Secondary endpoints and safety of remibrutinib in SD

At week 2, the earliest secondary timepoint, 29.3% of remibrutinib-treated patients achieved a complete TFS response vs 8.8% with placebo (treatment difference, 20.5%; 95% CI, 6.6–34.4).² At week 24, complete response rates were 32.8% vs 15.8% (treatment difference, 15.6%; 95% CI, 0.3–30.9).²

Remibrutinib reduced itch NRS by a least squares (LS) mean of 4.0 points from baseline at week 2, compared with 1.8 points for placebo (LS mean difference, −2.2; 95% CI, −3.2 to −1.2).² All primary and secondary endpoints reached statistical significance.²

Through week 24, safety in the SD population (remibrutinib, n = 58; placebo, n = 57) was consistent with safety in CSU, per the prescribing information.² In the pooled CSU trials, the most common adverse reactions were nasopharyngitis (11%), bleeding (9%), headache (7%), nausea (3%), and abdominal pain (3%), with no severe bleeding events.² Novartis noted no routine laboratory monitoring is required.¹

The label advises interrupting remibrutinib for 3 to 7 days before and after surgery and avoiding live or live-attenuated vaccines.² Concomitant strong or moderate CYP3A4 inhibitors and inducers should be avoided, as should use in patients with mild, moderate, or severe hepatic impairment.²

RemIND also evaluated remibrutinib in cold urticaria and cholinergic urticaria, and Novartis plans to submit the full dataset to health authorities globally.¹ The company is studying remibrutinib in hidradenitis suppurativa and food allergy and recently reported positive phase 3 REMODEL-1 and REMODEL-2 results vs teriflunomide in relapsing multiple sclerosis.¹

References

1. Novartis. Novartis Rhapsido (remibrutinib) receives FDA approval as first treatment for symptomatic dermographism (SD), expanding its use beyond chronic spontaneous urticaria (CSU). Published 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. Rhapsido. Prescribing information. Novartis Pharmaceuticals Corp; 2026. Accessed October 7, 2026. https://www.novartis.com/us-en/sites/novartis_us/files/rhapsido.pdf

3. HCPLive. Trial data and safety of remibrutinib for CSU. https://www.hcplive.com/view/trial-data-and-safety-of-remibrutinib-for-csu. Published July 15, 2026. Accessed October 7, 2026.