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Jump to Key Points The FDA has approved remibrutinib to treat adults with symptomatic dermographism (SD) inadequately controlled with H1 antihistamines, according to a press release from manufacturer Novartis.
Over 90% of adults with chronic hives experience chronic spontaneous urticaria (CSU) or SD, but more than half experience persistent symptoms despite taking H1 antihistamines, and no other treatments are approved for SD specifically, according to the company.
Remibrutinib, an oral Bruton tyrosine kinase inhibitor (BTKi), was approved for the treatment of CSU in adults in September 2025.
The new approval was supported by data from the phase 3 RemIND trial, in which significantly more patients with SD randomly assigned to remibrutinib achieved improvement in hives than those assigned to placebo after 12 weeks (29.3% vs 14.0%, P = .0229), and some patients showed improvement as early as 2 weeks. Safety data were similar to those seen in studies of CSU. The most common adverse events that occurred in at least 3% of study participants were nasal congestion, sore throat, runny nose, bleeding, headache, nausea, and abdominal pain. The recommended starting dose is 25 mg twice daily, according to the manufacturer website.
- FDA approved remibrutinib for adults with symptomatic dermographism inadequately controlled by H1 antihistamines.
- First FDA-approved SD-specific therapy; no prior approved SD treatment.
- RemIND phase 3: hives improvement at 12 weeks 29.3% vs 14.0% placebo; some benefit by 2 weeks.
- Common AEs ≥3%: nasal congestion, sore throat, rhinorrhea, bleeding, headache, nausea, abdominal pain.
- Oral BTKi dose: 25 mg BID; access/coverage and safety documentation may limit uptake.
The approval affirms the potential of BTK inhibition as a treatment strategy across immune-mediated diseases, according to the press release. Remibrutinib is approved for adults with CSU inadequately controlled by H1 antihistamines in the EU, the UK, and China. The drug has not been studied in children, but studies are in progress for the treatment of adults with hidradenitis suppurativa, food allergy, and multiple sclerosis.
Approval Empowers Patients, But Access May Be Tricky
The additional approval is important because SD and CSU are both forms of chronic urticaria, but they are distinct diseases, said Adam Friedman, MD, professor and chair of dermatology, George Washington University School of Medicine and Health Sciences, Washington, DC. “In SD, everyday friction or scratching can trigger intensely itchy wheals, and many patients remain symptomatic despite antihistamines,” said Friedman. “This approval provides disease-specific evidence and, importantly, the first FDA-approved treatment specifically for SD, which is validating for patients as well,” he said.
The approval will affect patient care by providing clinicians an evidence-based option for patients whose SD remains inadequately controlled with antihistamines, Friedman said.
Access will likely be the biggest initial barrier to incorporating remibrutinib into practice for SD patients, said Friedman. “FDA approval and insurance coverage are unfortunately not synonyms, so documenting the diagnosis, disease burden, and prior antihistamine treatment will be important,” he said. “Clinicians also need to understand the safety profile, including bleeding risk and considerations around surgery and live vaccines, with thoughtful patient selection and prescribing,” he emphasized.
Full prescribing information is available here.
The RemIND study was supported by Novartis.
