India Pharma Outlook Team | Thursday, 08 October 2026
Novartis Rhapsido’s FDA approval has expanded the use of remibrutinib to adults with symptomatic dermographism (SD) whose condition is inadequately controlled by H1 antihistamines.
The U.S. Food and Drug Administration's October 7 decision makes Rhapsido the first treatment specifically approved for SD, a form of chronic inducible urticaria in which scratching, rubbing, or pressure can trigger itchy hives.
The decision extends remibrutinib's role beyond chronic spontaneous urticaria (CSU), where it was previously approved.
More importantly, it highlights an area of unmet need in chronic skin disease, as more than 50 percent of SD patients remain symptomatic despite H1 antihistamine treatment.
Symptomatic dermographism is triggered by physical stimulation of the skin, making ordinary activities such as scratching or friction capable of producing raised, itchy welts.
It is considered the most prevalent form of chronic inducible urticaria, while chronic inducible urticaria overall affects an estimated 29 million adults globally. The challenge is that existing treatment has largely relied on H1 antihistamines. Novartis says more than half of patients with SD remain symptomatic despite this approach.
This creates a more specific treatment gap than the broader issue of chronic hives: patients can continue experiencing symptoms even after receiving standard antihistamine therapy.
The FDA approval therefore represents more than another indication for an established medicine. It creates a targeted treatment option specifically for patients whose SD is inadequately controlled.
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Remibrutinib is an oral, highly selective Bruton tyrosine kinase (BTK) inhibitor. Rather than acting simply as an antihistamine, it blocks the BTK pathway involved in signaling that leads to the release of histamine and other inflammatory mediators from immune cells involved in hives.
This mechanism is important to Novartis' broader strategy. The company is positioning remibrutinib as a targeted approach across both spontaneous and inducible forms of chronic urticaria, potentially giving the drug a wider role in immune-mediated disease.
The FDA decision was supported by the symptomatic dermographism cohort of the Phase III RemIND trial. At Week 12, 29.3 percent of patients receiving remibrutinib achieved a complete response from hives compared with 14.0 percent receiving placebo. Responses were also observed as early as Week 2.
The results are significant because the trial specifically enrolled patients who remained symptomatic despite second-generation H1 antihistamines. That makes the data directly relevant to the treatment gap behind the FDA's decision rather than simply demonstrating efficacy in an untreated population.
For Novartis, the SD approval could become a stepping stone for the broader development of remibrutinib. The company is investigating the drug in other immune-mediated conditions, including hidradenitis suppurativa and food allergy.
The immediate commercial and clinical significance, however, lies in expanding Rhapsido from CSU into another chronic urticaria setting.
With the new approval, remibrutinib becomes the only prescription treatment with approved uses in both CSU and SD, strengthening its position within Novartis' immunology portfolio.
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