FDA approves first treatment for hives triggered by skin scratching
The FDA approved Novartis' pill Rhapsido on Wednesday as the first treatment for symptomatic dermographism, a condition where light scratching or rubbing raises itchy hives. It is for adults whose symptoms are not controlled by antihistamines. In a trial, twice as many patients cleared their hives as on placebo.
People whose skin breaks out in hives from a light scratch now have an approved treatment for the first time.
The Food and Drug Administration on Wednesday approved remibrutinib, sold as Rhapsido by Novartis, for adults with symptomatic dermographism. It is for people whose symptoms are not controlled by antihistamines, the usual allergy pills.
In symptomatic dermographism, light pressure, rubbing or scratching makes raised, red, itchy hives appear within minutes, AJMC reported. Novartis says it is the most common type of chronic hives triggered by an outside cause. More than half of patients still have symptoms while taking antihistamines.
Remibrutinib is a pill. It blocks a pathway, called BTK, that helps release histamine, a key driver of hives and swelling.
The approval is based on a phase 3 trial called RemIND. At week 12, 29.3% of patients on the drug had their hives fully clear, compared with 14.0% on placebo. Some patients responded by week 2, Novartis said.
The most common side effects included stuffy nose, sore throat, runny nose, bleeding, headache, nausea and stomach pain. Novartis said no routine lab monitoring is needed.
"Remibrutinib offers, for the first time, an approach to treatment specifically for SD patients who remain inadequately controlled with H1 antihistamines alone," said Dr. Giselle Mosnaim of the University of Chicago, who led the trial.
Patient groups welcomed the news. "People living with this condition deserve treatment options developed specifically for this condition," said Kristen Willard, who leads We CU, a group for people with chronic hives.
The drug was first approved in September 2025 for chronic spontaneous urticaria, which is hives with no clear trigger. It is now the only treatment approved for both of the two most common forms of chronic hives.
Novartis is also testing the drug in other conditions, including food allergy, the skin disease hidradenitis suppurativa and multiple sclerosis. The company reported positive late-stage results in relapsing multiple sclerosis.
What we know: Rhapsido is now approved for two common types of chronic hives.
What we don't: How insurers will cover it for the new use.
Where outlets agree AJMC and Novartis both report the approval is the first for symptomatic dermographism in adults not controlled by H1 antihistamines.
Where they differ Novartis calls the trial results a meaningful step, but only about three in 10 patients on the drug had their hives fully clear by week 12.