FDA approves Rhapsido as first treatment for symptomatic dermographism

Novartis has received U.S. Food and Drug Administration approval for Rhapsido, also known as remibrutinib, as the first treatment specifically indicated for adults with symptomatic dermographism that is not adequately controlled by H1 antihistamines.

The approval expands the use of Rhapsido beyond chronic spontaneous urticaria and gives the medicine approved indications in the two most common forms of chronic hives.

Rhapsido is an oral, highly selective Bruton’s tyrosine kinase inhibitor.

The decision was supported by results from the symptomatic dermographism cohort of the Phase III RemIND study.

The trial enrolled patients who continued to experience symptoms despite treatment with second-generation H1 antihistamines.

At week 12, 29.3% of patients receiving Rhapsido achieved complete resolution of hives compared with 14.0% of those receiving placebo.

The difference was statistically significant, with a p value of 0.0229.

Responses were observed as early as week two.

Giselle Mosnaim, MD, MS, an allergist and immunologist at Endeavor Health and lead investigator of RemIND, said symptomatic dermographism has historically had limited treatment options.

She said remibrutinib provides a treatment specifically developed for patients whose symptoms remain inadequately controlled with antihistamines.

Symptomatic dermographism is the most common form of chronic inducible urticaria and can cause hives and itching following routine friction, scratching or rubbing of the skin.

Novartis said more than half of patients can remain symptomatic despite taking H1 antihistamines.

The safety profile of Rhapsido in symptomatic dermographism was consistent with findings previously observed in chronic spontaneous urticaria.

The most commonly reported adverse events through week 24 included nasopharyngitis, bleeding, headache, nausea and abdominal pain.

No routine laboratory monitoring is required with treatment.

Lindsey Finklea, MD, a dermatologist and RemIND investigator, said the availability of the first FDA approved medicine specifically for symptomatic dermographism could change how clinicians approach treatment for patients whose symptoms are not controlled with antihistamines.

With the latest approval, Rhapsido is now approved in both chronic spontaneous urticaria and symptomatic dermographism.

Novartis is also evaluating remibrutinib in other forms of chronic inducible urticaria, including cold urticaria and cholinergic urticaria.

The company plans to submit the broader RemIND dataset to regulatory authorities in other markets where appropriate.

Remibrutinib is also being studied across additional immune-mediated diseases, including hidradenitis suppurativa and food allergy.

Novartis has also reported positive Phase III results for the medicine in relapsing multiple sclerosis.

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Related Topics and Keywords

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