Novartis wins FDA approval for Rhapsido in symptomatic dermographism
Novartis has secured FDA approval for Rhapsido (remibrutinib) as the first treatment specifically indicated for adults with symptomatic dermographism (SD) whose symptoms remain inadequately controlled by H1 antihistamines. The decision, announced on 7 October 2026, makes remibrutinib the only prescription medicine in the US with approved uses across both SD and chronic spontaneous urticaria (CSU), the two most prevalent forms of chronic hives.
SD is the most common type of chronic inducible urticaria (CIndU), a category of hive conditions triggered by external stimuli rather than arising spontaneously. In SD, everyday skin contact such as scratching or clothing friction can provoke wheals and itch. Despite the condition's prevalence, more than half of patients remain symptomatic on standard H1 antihistamine therapy, leaving a substantial population with limited recourse prior to this approval.
Trial data and safety profile
The FDA decision is grounded in data from the SD cohort of the Phase III RemIND trial, which evaluated remibrutinib against placebo in patients who had failed second-generation H1 antihistamines. At Week 12, 29.3% of participants receiving remibrutinib achieved complete resolution of hives as measured by the Total Fric Score, compared with 14.0% in the placebo arm, a statistically significant difference (p=0.0229). Responses were recorded as early as Week 2, suggesting a relatively rapid onset of action.
The safety profile observed in SD was consistent with that seen in the CSU indication, and Novartis noted that no routine laboratory monitoring is required. The most commonly reported adverse events, each occurring in at least 3% of participants, included nasopharyngitis, bleeding, headache, nausea, and abdominal pain. No new safety signals emerged in the SD-specific analysis.
Giselle Mosnaim, lead RemIND trial investigator and Clinical Professor at the University of Chicago Pritzker School of Medicine, said remibrutinib "offers, for the first time, an approach to treatment specifically for SD patients who remain inadequately controlled with H1 antihistamines alone."
BTK inhibition and the broader pipeline
The approval adds commercial weight to Novartis's strategy of expanding BTK inhibition beyond oncology, where the class first achieved prominence, into immune-mediated disease. Remibrutinib works by blocking the BTK pathway that drives histamine release, the principal mediator of wheals and itch in urticaria. Novartis is also evaluating the compound in hidradenitis suppurativa, food allergy, and relapsing multiple sclerosis, where Phase III REMODEL-1/-2 trials recently returned positive topline results showing a meaningful reduction in annualised relapse rates versus teriflunomide.
The BTKi class in immunology is increasingly contested. AstraZeneca's acalabrutinib and AbbVie's ibrutinib have established oncology franchises, and several companies are advancing next-generation selective BTKi compounds into autoimmune indications. Remibrutinib's highly selective profile, combined with the absence of routine monitoring requirements, may support tolerability arguments in a population that is not accustomed to the close surveillance typical of haematology patients. Rhapsido already holds approvals in the EU, UK, and China for CSU.
Novartis said it plans to submit the full RemIND dataset, which also includes cohorts in cold urticaria and cholinergic urticaria, to health authorities globally. Those additional CIndU indications, if approved, could further expand the addressable patient population and reinforce remibrutinib's positioning as a platform asset in immune-mediated skin conditions. Clinicians and payers will watch closely for real-world durability data and for pricing signals as the drug enters a condition area where patients have historically managed on inexpensive generic antihistamines.