FDA Approves Rhapsido (Remibrutinib) — the First-Ever Treatment for Symptomatic Dermographism
October 7, 2026. Novartis announced FDA approval of remibrutinib (Rhapsido) — an oral, highly selective Bruton's tyrosine kinase (BTK) inhibitor — as "the first treatment for adults with symptomatic dermographism (SD) inadequately controlled by H1 antihistamines." Dermographism ("skin writing" — wheals triggered by pressure/light scratching of the skin) is, per Novartis, the most prevalent form of chronic inducible urticaria, and more than 50% of SD patients remain symptomatic despite H1 antihistamines. This is remibrutinib's second U.S. indication, following its CSU approval just over a year ago — making it the only prescription treatment approved for both of the two most common chronic-hive conditions (Novartis says >90% of adults with chronic hives have CSU or SD).
The approval is based on the SD cohort of the Phase 3 RemIND trial (NCT05976243). Per Dermatology Times: "At week 12, 29.3% of patients treated with remibrutinib achieved complete response from hives vs 14.0% with placebo (P = .0229)," with responses seen as early as week 2. Through week 24 the safety profile was consistent with the CSU experience — common adverse events (≥3%) were nasopharyngitis, bleeding, headache, nausea, and abdominal pain, with no routine laboratory monitoring required. RemIND is also testing cold urticaria and cholinergic urticaria, and the drug remains in trials for hidradenitis suppurativa and food allergy; Novartis plans global submissions of the full RemIND data set.
Investigator Lindsey Finklea, MD: "Having the first FDA-approved medicine specifically for SD marks an important change in how clinicians can approach care and offers renewed hope for patients whose symptoms are not adequately controlled by H1 antihistamines." For a condition long managed with antihistamines and avoidance alone, the approval establishes a first targeted option — and extends the BTK-inhibitor class deeper into allergy/immunology.