FDA clears Novartis Rhapsido as first treatment for symptomatic dermographism

Novartis said the Food and Drug Administration approved Rhapsido (remibrutinib) as the first treatment for adults with symptomatic dermographism whose hives and itch stay uncontrolled on H1 antihistamines.

What regulators cleared

On Oct. 7, 2026, Novartis announced that the Food and Drug Administration approved Rhapsido (remibrutinib), an oral, highly selective Bruton's tyrosine kinase inhibitor, as the first treatment for adults with symptomatic dermographism inadequately controlled by H1 antihistamines. The company says Rhapsido is now the only prescription medicine with approved uses in both chronic spontaneous urticaria and symptomatic dermographism when antihistamines alone are not enough.

Symptomatic dermographism is a form of chronic inducible urticaria in which everyday friction, scratching, or rubbing of the skin can trigger hives and itch. Novartis cites that it is the most prevalent type of chronic inducible urticaria and that more than half of patients remain symptomatic despite H1 antihistamines. The company also says more than 90% of adults with chronic hives experience chronic spontaneous urticaria or symptomatic dermographism.

How RemIND was built

The approval rests on the symptomatic dermographism cohort of the Phase 3 RemIND trial (NCT05976243), described in Novartis's release and in the U.S. prescribing information. RemIND enrolled 115 adults with symptomatic dermographism for at least four months that remained inadequately controlled on H1 antihistamines, defined by a Total Fric Score of at least 3 on the FricTest 4.0 and an itch score of at least 5 on a 0–10 scale shortly after the provocation test.

Patients were randomized 1:1 to remibrutinib 25 mg or placebo orally twice daily for 24 weeks in a double-blind period, then continued in a 28-week open-label period in which all patients received remibrutinib. Efficacy for the approval is based on the 115 patients in the placebo-controlled period. The recommended dose on the label is 25 mg orally twice daily with or without food; tablets should be swallowed whole, and treatment should be interrupted for three to seven days before and after surgery because of bleeding risk.

The Week 12 response gap

The primary endpoint was the proportion of patients with a complete response on the Total Fric Score — a score of zero after FricTest provocation — at Week 12. Novartis and the label report that 29.3% of patients on remibrutinib (17 of the treated arm) achieved that complete response versus 14.0% on placebo (8 patients), a 15 percentage-point treatment difference. The company release cites p=0.0229 and says responses were seen as early as Week 2.

Safety the label and company put first

In clinical trials up to Week 24, Novartis says the safety profile in symptomatic dermographism was consistent with the chronic spontaneous urticaria experience and that no routine laboratory monitoring is required. The prescribing information lists common adverse reactions with incidence of at least 3% as nasopharyngitis (nasal congestion, sore throat, and runny nose), bleeding, headache, nausea, and abdominal pain. The label carries a warning for risk of bleeding, including mucocutaneous bleeding, and advises avoiding live attenuated vaccines while on treatment.

What the approval does not settle

List price, insurer coverage, and any change to Novartis's financial guidance were not in Wednesday's materials. RemIND also evaluated other inducible urticaria subtypes, and remibrutinib remains in studies for other immune-mediated conditions — none of which Wednesday's approval settles for symptomatic dermographism patients waiting on access and real-world use.