US FDA expands use of Novartis drug for chronic skin condition

Oct 7 — The US Food and Drug Administration has expanded the use ​of Novartis' drug to treat adults with a chronic skin condition that causes recurring itchy welts, the Swiss ‌drugmaker said on Wednesday.

The condition, called symptomatic dermographism, is a form of chronic ⁠hives in which scratching, ​rubbing or friction on the ⁠skin can trigger itchy welts.

The approval adds to momentum for ‌the drug, remibrutinib, ‌which investors have increasingly focused on after recent late-stage ⁠failures of the company's cholesterol ⁠drug pelacarsen and muscle-wasting disease therapy del-desiran increased scrutiny of its pipeline.

• Remibrutinib, branded as Rhapsido, is the first FDA-approved treatment specifically for adults with symptomatic dermographism whose symptoms are not adequately controlled with antihistamines, Novartis said.

• The ‌approval expands the drug's use beyond ​chronic spontaneous urticaria, another common form of chronic hives for which it is already approved in the United States.

• In the late-stage study, 29.3% of patients taking remibrutinib achieved complete resolution of hives after 12 weeks, compared with 14% of patients receiving placebo.

• Patients receiving remibrutinib began ​showing improvements as early as two weeks after starting treatment, the ‌company said.

• Novartis ‌said ⁠the drug's safety profile was consistent with earlier studies, with the most common side effects including nasal congestion, sore throat, headache, nausea and abdominal pain.

• The approval follows positive late-stage ‌trial results for remibrutinib ​in relapsing multiple sclerosis, a disease ‌in which the ⁠immune system ​attacks the nervous system.

(Reporting by Sahil Pandey in Bengaluru; Editing by ​Devika Syamnath)

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