FDA Greenslights Novartis's Rhapsido as First Treatment for Chronic Friction Hives

Novartis AG (NYSE:NVS) on Wednesday secured the U.S. Food and Drug Administration (FDA) approval for Rhapsido (remibrutinib) to treat adults with symptomatic dermographism (SD) who do not achieve adequate control with H1 antihistamines.

Dermographism, also known as Dermatographia, is a common skin condition where minor scratching, rubbing, or pressure causes raised, red welts or lines to form on the skin.

This marks the first FDA approval for a treatment specifically targeting SD, a condition where everyday activities like scratching or rubbing the skin can trigger chronic hives and itching.

Significant Advancement For Chronic Hives

SD and chronic spontaneous urticaria (CSU) account for more than 90% of chronic hives cases in adults.

With this latest approval, Rhapsido is now the only prescription medication approved to treat both SD and CSU when antihistamines fall short.

Clinical Trial Data Backs Approval

The FDA’s decision is supported by data from the SD cohort of the Phase 3 RemIND clinical trial. The study focused on patients whose symptoms persisted despite using second-generation H1 antihistamines.

According to the data, patients treated with Rhapsido achieved significantly higher rates of complete hive clearance compared to those given a placebo.

At the 12-week mark, 29.3% of patients on Rhapsido experienced complete response from hives, compared to just 14.0% in the placebo group. Notably, some patients began seeing results as early as week two.

Consistent Safety Profile and Future Research

Clinical trials up to 24 weeks showed a consistent safety profile for Rhapsido in both SD and CSU.

Novartis is also evaluating remibrutinib in other forms of chronic inducible urticaria (CIndU), such as cold urticaria and cholinergic urticaria, as part of the RemIND study.

Furthermore, Novartis is studying remibrutinib for other immune-mediated conditions, including hidradenitis suppurativa and food allergies.

The company also recently reported positive topline results from Phase 3 trials in relapsing multiple sclerosis.

NVS Price Action: Novartis shares were up 1.91% at $143.47 at the time of publication on Wednesday, according to Benzinga Pro data.

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