Remibrutinib Approval Brings First On-Label Option for Symptomatic Dermographis

The recent FDA approval of remibrutinib (Rhapsido) for symptomatic dermographism (SD) gives clinicians an on-label option for a condition long managed with off-label therapies, Raj Chovatiya, MD, PhD, MSCI, said in an interview with Dermatology Times.

Chovatiya, an associate professor at the Rosalind Franklin University Chicago Medical School and founder and director of the Center for Medical Dermatology and Immunology Research in Chicago, Illinois, spoke with Dermatology Times ahead of the 2026 Fall Clinical Dermatology Conference about the approval and what it means for the field and for patients. He called the update “a really exciting piece of news that I’m happy that I can use to help my patients.”

The FDA approved remibrutinib on October 7, 2026, as the first treatment for adults with SD inadequately controlled by H1 antihistamines.¹

What Is Symptomatic Dermographism?

SD belongs to the inducible forms of urticaria, which Chovatiya described as the group of chronic urticarial diseases in which hives develop in response to outside influences and clear triggers. Most clinicians know it from the exam room. He pointed to the familiar experience of “tracing with a little bit of pressure on somebody’s back and noticing that indeed urticaria can form.”

The burden goes well beyond an exam finding. Chovatiya characterized SD as “an extremely uncomfortable and chronic issue for a lot of our patients dealing with chronic urticaria.” According to Novartis, more than 50% of patients with SD remain symptomatic despite H1 antihistamines.¹

How Does the Approval Change Symptomatic Dermographism Treatment?

Until now, patients whose SD persisted on antihistamines had no approved next step. “I think that for many folks in the world of treatment of dermatology, there’s been a lot of off-label use of therapies,” Chovatiya told Dermatology Times. An on-label indication, he said, is an exciting movement for the field.

The approval is based on the SD cohort of the phase 3 RemIND trial, which enrolled patients who remained symptomatic on second-generation H1 antihistamines. At week 12, 29.3% of patients receiving remibrutinib achieved complete resolution of hives compared with 14% of those receiving placebo, and improvements appeared as early as week 2. The safety profile in SD was consistent with that seen in chronic spontaneous urticaria (CSU), with no routine laboratory monitoring required.¹

What Is Next for Remibrutinib Beyond CSU and Symptomatic Dermographism?

The SD indication builds on the drug’s first approval, granted September 30, 2025, for patients with CSU who remain symptomatic despite H1 antihistamine therapy.² In Chovatiya’s view, the oral Bruton tyrosine kinase inhibitor “has really been game changing for us in the world of chronic spontaneous urticaria.”

He expects the label to keep growing. RemIND also showed significantly higher complete response rates than placebo in cold urticaria and cholinergic urticaria.³ “I say this is probably one of several more indications to come in the life of remibrutinib,” Chovatiya said.

References

1. Novartis receives FDA approval for Rhapsido (remibrutinib), the only oral, targeted BTKi treatment for chronic spontaneous urticaria (CSU). News release. Novartis. September 30, 2025. Accessed October 8, 2026. https://www.globenewswire.com/news-release/2025/09/30/3159065/0/en/Novartis-receives-FDA-approval-for-Rhapsido-remibrutinib-the-only-oral-targeted-BTKi-treatment-for-chronic-spontaneous-urticaria-CSU.html
2. Remibrutinib meets primary endpoints in phase 3 trial for chronic inducible urticaria subtypes. Dermatology Times. February 18, 2026. Accessed October 8, 2026. https://www.dermatologytimes.com/view/remibrutinib-meets-primary-endpoints-in-phase-3-trial-for-chronic-inducible-urticaria-subtypes