FDA Grants Rhapsido First Symptomatic Dermographism Approval

The FDA granted the first symptomatic dermographism approval to Rhapsido (remibrutinib) on 7 October 2026. The oral Bruton’s tyrosine kinase inhibitor is already marketed by Novartis for chronic spontaneous urticaria. The label covers adults whose hives and itch remain uncontrolled on H1 antihistamines.

Symptomatic dermographism ranks as the most common form of chronic inducible urticaria. Friction, scratching or pressure on the skin triggers wheals and itching within minutes, so patients react to clothing, towels, seatbelts and handshakes.

The approval gives Rhapsido the only prescription indication that spans the two most frequent types of chronic hives. Novartis states that more than 90% of adults with chronic hives have either chronic spontaneous urticaria or symptomatic dermographism, and more than 50% of those with symptomatic dermographism stay symptomatic on H1 antihistamines. No other approved treatment exists for patients who do not respond to antihistamines.

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What the symptomatic dermographism approval covers

The indication applies only to adults whose symptoms persist despite H1 antihistamines. This matches the population covered when the FDA approved the drug for chronic spontaneous urticaria just over a year earlier and leaves Rhapsido as the sole labelled option for the two conditions that represent the large majority of chronic hives cases.

“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 investigator of the RemIND trial. “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.”

What the RemIND trial showed

The approval is based on the symptomatic dermographism cohort of the Phase III RemIND trial. Patients in that cohort remained symptomatic while taking second-generation H1 antihistamines. The primary endpoint was complete response from hives measured by the Total Fric Score.

Source: Novartis media release, 7 October 2026, reporting the RemIND SD cohort

At Week 12, complete response occurred in 29.3% of patients on Rhapsido versus 14.0% on placebo, a difference that reached statistical significance (p=0.0229). Responses appeared as early as Week 2.

The wider remibrutinib programme

The RemIND trial also tested remibrutinib in other forms of chronic inducible urticaria, including cold urticaria (ColdU) and cholinergic urticaria (CholU). Novartis intends to submit the complete RemIND data set to health authorities worldwide where relevant. Remibrutinib is under investigation in hidradenitis suppurativa (HS) and food allergy as well.

Positive topline results from the Phase III REMODEL-1 and REMODEL-2 trials in relapsing multiple sclerosis (RMS) showed a clinically meaningful reduction in annualized relapse rates and a clinically meaningful delay in disability progression versus teriflunomide. The safety profile was favorable and free of liver safety signals, consistent with findings in chronic spontaneous urticaria.

What it means for patients and clinicians

“For people living with SD, seemingly routine contact with the skin can trigger hives and itch,” said Lindsey Finklea, MD, a dermatologist and adjunct professor at the University of Texas at San Antonio and a RemIND trial investigator. “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.”

“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 that supports people with chronic urticaria. “People living with this condition deserve treatment options developed specifically for this condition, and we are hopeful about what this milestone means for the community.”

Victor Bultó, president of Novartis US, noted that the decision extends the first FDA-approved indication for Rhapsido in chronic spontaneous urticaria from just over a year ago. “With Rhapsido now approved for the two most common forms of chronic hives, more people may have the opportunity to find relief from persistent itch, regain confidence in their daily lives, and focus less on their symptoms and more on the moments that matter,” he said.

Source: Novartis media release, 7 October 2026