The USFDA has approved Novartis’ Rhapsido (remibrutinib) as the first treatment specifically for adults with symptomatic dermographism (SD) whose symptoms are inadequately controlled by H1 antihistamines.

 

The development marks a major step forward for patients living with this often debilitating form of chronic hives.

 

Symptomatic dermographism can cause hives and intense itching in response to everyday skin friction, scratching or rubbing, turning routine physical contact into a persistent source of discomfort.

 

Rhapsido is an oral, highly selective Bruton’s tyrosine kinase inhibitor (BTKi). With the latest approval, it becomes the only prescription treatment indicated for both chronic spontaneous urticaria (CSU) and symptomatic dermographism when antihistamines alone fail to adequately control symptoms. More than 90% of adults with chronic hives experience one of these two conditions.

 

“SD is a chronic, debilitating condition with historically limited treatment options,” said Giselle Mosnaim, 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’s decision was based on data from the symptomatic dermographism cohort of the Phase III RemIND clinical trial, which evaluated patients who continued to experience symptoms despite treatment with second-generation H1 antihistamines.

 

The results showed that Rhapsido delivered significantly higher rates of complete hive response than placebo, as measured by the Total Fric Score.

 

At Week 12, 29.3% of patients treated with Rhapsido achieved a complete response from hives, compared with 14.0% receiving placebo. Responses were observed as early as Week 2.

 

The trial also showed a consistent safety profile through Week 24 in patients with SD and CSU. The most common adverse events, occurring in at least 3% of patients, included nasopharyngitis (nasal congestion, sore throat and runny nose), bleeding, headache, nausea and abdominal pain.

 

For people living with symptomatic dermographism, the approval represents more than a regulatory milestone: it brings a treatment specifically developed for a condition that can affect everyday comfort and quality of life.

 

“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 hopeful about what this milestone means for the community.”

 

Lindsey Finklea, a Dermatologist and Adjunct Professor at the University of Texas at San Antonio and RemIND trial investigator, highlighted the impact of symptoms triggered by routine physical contact.

 

“For people living with SD, seemingly routine contact with the skin can trigger hives and itch,” said Lindsey Finklea, a Dermatologist and Adjunct Professor at the University of Texas at San Antonio and 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.”

 

The approval strengthens Rhapsido’s position in the treatment of chronic hives, making it the only treatment indicated for the two most common forms of the condition: CSU and SD.

 

The RemIND study also evaluated remibrutinib in other forms of chronic inducible urticaria (CIndU), including cold urticaria (ColdU) and cholinergic urticaria (CholU). Novartis plans to submit the full RemIND dataset to health authorities globally, where appropriate.

 

“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. 

 

“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. We are proud to advance the science of BTK inhibition as we work to bring new treatment options to patients with unmet needs across immunology and beyond.”

 

Novartis is continuing to investigate remibrutinib in other immune-mediated conditions, including hidradenitis suppurativa (HS) and food allergy.

 

The company has also announced positive topline results from its Phase III REMODEL-1/-2 trials in relapsing multiple sclerosis (RMS).