Novartis Wins FDA Approval for Rhapsido in Symptomatic Dermographism

Novartis announced on October 7, 2026, that the U.S. Food and Drug Administration (FDA) approved Rhapsido (remibrutinib) as the first treatment for adults with symptomatic dermographism (SD) inadequately controlled by H1 antihistamines. The decision adds a second U.S. indication for the oral, highly selective Bruton’s tyrosine kinase inhibitor (BTKi), which is already approved in chronic spontaneous urticaria (CSU).

SD is a form of chronic hives in which symptoms can be triggered by everyday skin friction, scratching, or rubbing. Rhapsido works by blocking the BTK pathway involved in the release of histamine, which Novartis describes as a key driver of hives (wheals) and swelling. More than 90% of adults with chronic hives experience CSU or SD, according to the company. With the new approval, Novartis said Rhapsido becomes the only prescription treatment with approved uses in both conditions when antihistamines alone do not control symptoms, citing company data on file from August 2026.

Phase III RemIND Data

The FDA decision rests on data from the SD cohort of the Phase III RemIND clinical trial, conducted in patients who remained symptomatic on second-generation H1 antihistamines. At Week 12, 29.3% of patients treated with Rhapsido achieved complete response from hives, as measured by the Total Fric Score, compared with 14.0% of patients receiving placebo (p=0.0229), with responses seen as early as Week 2, according to prescribing information cited in the announcement. Novartis summarized the result as twice as many treated adults achieving complete hive resolution by Week 12 versus placebo.

In clinical trials up to Week 24, Rhapsido demonstrated a safety profile in SD consistent with that in CSU, with no routine lab monitoring required. The most common adverse events, occurring in at least 3% of patients, were nasopharyngitis (nasal congestion, sore throat, and runny nose), bleeding, headache, nausea, and abdominal pain.

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, said: “SD is a chronic, debilitating condition with historically limited treatment options. 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.”

Novartis described SD as the most prevalent type of chronic inducible urticaria (CIndU), citing a 2020 paper by Pozderac and colleagues in Acta Dermatovenerol Alp Pannonica Adriat. The company also cited the Urticaria Voices study, presented at the European Academy of Allergy and Clinical Immunology Congress in 2025, which found that more than 50% of CIndU patients remain symptomatic despite taking H1 antihistamines.

Kristen Willard, executive director of We CU, a global community supporting people with chronic urticaria through awareness, advocacy, education, and research, said the approval represents important progress for the SD community, adding that people living with the condition deserve treatment options developed specifically for it.

Wider CIndU Program and Pipeline

Beyond SD, the RemIND study also evaluated remibrutinib in additional forms of CIndU, including cold urticaria and cholinergic urticaria. Novartis said it plans to submit the full RemIND dataset to health authorities globally, where appropriate. Lindsey Finklea, MD, a dermatologist and adjunct professor at the University of Texas at San Antonio and a RemIND trial investigator, said 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.

In the United States, Rhapsido is now approved for adults with CSU and for adults with SD inadequately controlled by H1 antihistamines. The drug is also approved in the European Union, the United Kingdom, and China for adults with CSU inadequately controlled by H1 antihistamines. “Today’s approval marks an important milestone for people living with SD and builds on the first FDA-approved indication for Rhapsido in CSU just over a year ago,” said Victor Bultó, President, US, Novartis.

Remibrutinib continues to be studied in other immune-mediated conditions, including hidradenitis suppurativa and food allergy, as well as multiple sclerosis. Novartis said it recently announced positive topline results from the Phase III REMODEL-1 and REMODEL-2 trials in relapsing multiple sclerosis, in which remibrutinib demonstrated a clinically meaningful reduction in annualized relapse rates and a clinically meaningful delay in disability progression versus teriflunomide, with a favorable safety profile and no liver safety signals. The company said it plans to present the late-breaking data at MSToronto2026.