The US Food and Drug Administration has approved Novartis' oral drug remibrutinib (Rhapsido) as the first disease-specific treatment for adults with symptomatic dermographism inadequately controlled by antihistamines. Supported by the phase 3 RemIND trial, which showed a 29.3% improvement rate compared to 14% for placebo, the approval bolsters Novartis' pipeline following recent late-stage drug failures. However, experts warn that securing insurance coverage remains a key hurdle for patient access.
FDA approval of remibrutinib
- ▪The US Food and Drug Administration approved Novartis' oral drug remibrutinib, branded as Rhapsido, to treat adults with symptomatic dermographism inadequately controlled by H1 antihistamines
- ▪Remibrutinib is the first FDA-approved treatment specifically for symptomatic dermographism, a form of chronic hives triggered by skin friction, rubbing, or scratching
- ▪The FDA's approval of remibrutinib for symptomatic dermographism expands the use of remibrutinib beyond chronic spontaneous urticaria, for which remibrutinib was approved in the United States in September 2025
RemIND clinical trial
- ▪In the Novartis-sponsored phase 3 RemIND trial, symptomatic dermographism patients taking remibrutinib showed improvements as early as two weeks, with 29.3% achieving complete resolution or improvement in hives after 12 weeks, compared to 14.0% receiving placebo
- ▪The phase 3 RemIND clinical trial, which evaluated remibrutinib for symptomatic dermographism, was supported by the Swiss drugmaker Novartis
Dosing and patient populations
- ▪The recommended starting dose for remibrutinib for treating symptomatic dermographism is 25 mg taken orally twice daily
- ▪Although approved for adults, the oral drug remibrutinib has not yet been studied in children
Remibrutinib safety considerations
- ▪George Washington University dermatology professor Adam Friedman emphasized that clinicians must understand remibrutinib's safety profile, including bleeding risk and considerations around surgery and live vaccines
- ▪The most common adverse events occurring in at least 3% of participants in the phase 3 RemIND trial of remibrutinib include nasal congestion, sore throat, runny nose, bleeding, headache, nausea, and abdominal pain
Insurance coverage challenges
- ▪George Washington University dermatology professor Adam Friedman stated that insurance coverage will likely be the biggest initial barrier to incorporating remibrutinib into clinical practice for symptomatic dermographism patients
- ▪George Washington University dermatology professor Adam Friedman emphasized that clinicians must document symptomatic dermographism diagnosis, disease burden, and prior antihistamine treatment to help secure insurance coverage for remibrutinib
Remibrutinib trials for other conditions
- ▪The approval of remibrutinib for symptomatic dermographism follows positive late-stage clinical trial results for remibrutinib in treating relapsing multiple sclerosis
- ▪Novartis is currently conducting clinical studies of remibrutinib for the treatment of adults with hidradenitis suppurativa, food allergy, and multiple sclerosis
Global approvals and pipeline
- ▪The FDA's approval of remibrutinib for symptomatic dermographism adds momentum to Novartis' pipeline following recent late-stage failures of Novartis' cholesterol drug pelacarsen and muscle-wasting disease therapy del-desiran
- ▪Remibrutinib is already approved for adults with chronic spontaneous urticaria inadequately controlled by H1 antihistamines in the European Union, the United Kingdom, and China
Debatable claims
- ▪Prescribing remibrutinib off-label to children is justified
- ▪Insurers should widely cover remibrutinib for symptomatic dermographism
- ▪Remibrutinib's clinical benefits outweigh its safety risks
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