US FDA expands use of Novartis drug for chronic skin condition
NVS•The FDA expanded approval of Novartis’ remibrutinib, branded as Rhapsido, to treat adults with symptomatic dermographism whose symptoms are not adequately controlled with antihistamines. In a late-stage study, 29.3% of patients taking the drug achieved complete hive resolution after 12 weeks, compared with 14% receiving placebo.
1. Expanded approval
The US Food and Drug Administration expanded remibrutinib’s use to adults with symptomatic dermographism, a form of chronic hives in which scratching, rubbing or friction can trigger itchy welts. Novartis said Rhapsido is the first FDA-approved treatment specifically for adults with the condition whose symptoms are not adequately controlled with antihistamines.
2. Trial results and safety
In a late-stage study, 29.3% of patients taking remibrutinib achieved complete resolution of hives after 12 weeks, compared with 14% receiving placebo. The company said patients began showing improvements as early as two weeks and that the drug’s safety profile was consistent with earlier studies; common side effects included nasal congestion, sore throat, headache, nausea and abdominal pain.
3. Other uses
The approval expands remibrutinib’s use beyond chronic spontaneous urticaria, another form of chronic hives for which it is already approved in the United States. The approval follows positive late-stage trial results for the drug in relapsing multiple sclerosis.
