The U.S. Food and Drug Administration (FDA) has approved Novartis’ Rhapsido® (remibrutinib) for adults with symptomatic dermographism (SD) whose symptoms are not adequately controlled with H1 antihistamines, making it the first FDA-approved treatment specifically for the condition.
The approval expands the use of Rhapsido beyond chronic spontaneous urticaria (CSU), where the medicine was previously approved. Rhapsido is now approved in the U.S. for adults with both CSU and symptomatic dermographism when H1 antihistamines do not adequately control symptoms.
The FDA approval is based on results from the symptomatic dermographism cohort of the Phase III RemIND clinical trial. The study evaluated adults who remained symptomatic despite treatment with second-generation H1 antihistamines.
In the trial, Rhapsido demonstrated higher rates of complete hive resolution compared with placebo. At Week 12, 29.3% of patients treated with Rhapsido achieved a complete response from hives compared with 14.0% of patients receiving placebo. The difference was statistically significant, with a p-value of 0.0229. Responses were observed as early as Week 2.
Symptomatic dermographism is a form of chronic inducible urticaria (CIndU) in which physical stimulation of the skin, including rubbing, scratching or friction, can trigger raised hives and itching. It is reported to be the most prevalent form of chronic inducible urticaria, and more than half of patients may remain symptomatic despite treatment with H1 antihistamines.
With the latest FDA decision, Rhapsido becomes the only prescription treatment approved in the U.S. for the two most common forms of chronic hives, CSU and symptomatic dermographism, when symptoms are inadequately controlled by H1 antihistamines.
Novartis is also evaluating remibrutinib in other forms of chronic inducible urticaria, including cold urticaria (ColdU) and cholinergic urticaria (CholU). The company said it plans to submit the full RemIND dataset to health authorities globally where appropriate.
In clinical trials through Week 24, Rhapsido demonstrated a consistent safety profile in symptomatic dermographism and CSU. The most common adverse events, occurring in at least 3% of patients, included nasopharyngitis, bleeding, headache, nausea and abdominal pain. Novartis also highlighted that routine laboratory monitoring is not required with Rhapsido.
Rhapsido is an oral, highly selective Bruton’s tyrosine kinase (BTK) inhibitor. The medicine blocks the BTK pathway involved in the release of histamine, a key driver of hives and swelling.
The latest approval is part of Novartis’ broader development program for remibrutinib across immune-mediated diseases. The company is studying the medicine in conditions including hidradenitis suppurativa, food allergy and multiple sclerosis.
Novartis recently reported positive topline results from its Phase III REMODEL-1 and REMODEL-2 trials in relapsing multiple sclerosis. According to the company, remibrutinib demonstrated a clinically meaningful reduction in annualized relapse rates and a delay in disability progression compared with teriflunomide, with a favorable safety profile and no liver safety signals.
The FDA approval provides a new treatment option for adults with symptomatic dermographism who continue to experience hives and itching despite H1 antihistamine treatment and further expands the clinical development of BTK inhibition across immune-mediated diseases.
