Oct 7 (Reuters) – 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)
Comments