Novartis’ Rhapsido Getsa FDA Approval As First Treatment For Symptomatic Dermographism

- In Phase III RemIND trial, twice as many adults taking Rhapsido achieved complete hive resolution by Week 12 vs placebo, with responses seen by Week 21 -- SD is most prevalent type of chronic inducible urticaria (CIndU)2; more than 50% of patients remain symptomatic despite taking H1 antihistamines3 -- Rhapsido showed safety profile in SD consistent with CSU, with no routine lab monitoring required1 -- Approval builds on established role of Rhapsido in CSU and highlights potential of BTK inhibition across immune-mediated diseases Basel, October 7, 2026 -- Novartis announced today that the U.S. Food and Drug Administration (FDA) approved Rhapsido(R) (remibrutinib), an oral, highly selective Bruton's tyrosine kinase inhibitor (BTKi), as the first treatment for adults with symptomatic dermographism (SD) inadequately controlled by H1 antihistamines. The approval represents an important advancement for people whose chronic hives and itch can be triggered by everyday skin friction, scratching, or rubbing. Over 90% of adults with chronic hives experience chronic spontaneous urticaria (CSU) or SD. Rhapsido is the only prescription treatment with approved uses in both CSU and SD when antihistamines alone do not control symptoms.(4) "SD is a chronic, debilitating condition with historically limited treatment options," said Giselle Mosnaim, MD, MS, an Allergist and Immunologist at Endeavor Health, Clinical Professor at the University of Chicago Pritzker School of Medicine, and lead RemIND trial investigator. "Remibrutinib offers, for the first time, an approach to treatment specifically for SD patients who remain inadequately controlled with H1 antihistamines alone, representing a meaningful step forward for this population." The FDA approval is based on data from the SD cohort of the Phase III RemIND clinical trial in patients who remained symptomatic on second-generation H1 antihistamines. Rhapsido demonstrated higher rates of complete response from hives compared to placebo as measured by the Total Fric Score.(1) At Week 12, significantly more patients treated with Rhapsido versus placebo achieved complete response from hives (29.3% vs 14.0% with placebo; p=0.0229), with responses seen as early as Week 2.(1) In clinical trials up to Week 24, Rhapsido demonstrated a consistent safety profile in SD and CSU.(1) The most common adverse events (incidence >=3%) were nasal congestion, sore throat, and runny nose (nasopharyngitis), bleeding, headache, nausea, and abdominal pain.(1) "As both a patient and an advocate, I know how important it is for SD to be recognized and understood," said Kristen Willard, Executive Director of We CU, a global community supporting people with chronic urticaria (CU) through awareness, advocacy, education, and research. "For the SD community, the approval of remibrutinib represents important progress. People living with this condition deserve treatment options developed specifically for this condition, and we are hopefu