FDA expands Novartis drug use for chronic skin condition

• Remibrutinib is already approved for chronic spontaneous urticaria; this expands its use to symptomatic dermographism, a form of chronic hives triggered by scratching or skin friction
• In late-stage trials, 29.3% of patients achieved complete resolution of hives after 12 weeks versus 14% on placebo, with improvements appearing as early as two weeks
• The approval provides a boost for Novartis' pipeline amid investor scrutiny following setbacks with cholesterol drug pelacarsen and muscle-wasting therapy del-desiran

FDA Expands Novartis Drug Approval for Chronic Skin Condition

The U.S. Food and Drug Administration has approved expanded use of Novartis' remibrutinib (branded as Rhapsido) to treat adults with symptomatic dermographism, a chronic skin condition causing itchy welts triggered by scratching or friction. The announcement came on October 7, 2026.

Key Details:

Remibrutinib becomes the first FDA-approved treatment specifically for symptomatic dermographism patients whose symptoms aren't adequately controlled by antihistamines. The drug was previously approved for chronic spontaneous urticaria, another form of chronic hives.

Clinical Trial Results:

In late-stage studies, 29.3% of patients taking remibrutinib achieved complete resolution of hives after 12 weeks, compared to just 14% receiving placebo. Patients showed improvement as early as two weeks after starting treatment. Common side effects included nasal congestion, sore throat, headache, nausea, and abdominal pain, consistent with earlier safety profiles.

Market Implications:

This approval adds momentum to Novartis' pipeline amid increased investor scrutiny following setbacks with cholesterol drug pelacarsen and muscle-wasting therapy del-desiran. Remibrutinib has become a focus for investors seeking positive developments in the company's drug portfolio.

The expansion follows recent approval for the drug in relapsing multiple sclerosis, demonstrating Novartis' strategy to broaden remibrutinib's therapeutic applications across immune-related conditions. This diversification could strengthen the drug's commercial potential and support Novartis' revenue growth prospects in specialty therapeutics.