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The Food and Drug Administration (FDA) has approved oral remibrutinib, a new drug product, as a second-line treatment for chronic spontaneous urticaria (CSU). Remibrutinib has a unique mechanism to block the activity of Bruton’s tyrosine kinase (BTK), stopping a key pathway of the immune response in CSU, according to a manufacturer press release. The condition is thought to be caused by immune dysregulation, and it is believed that once activated, BTK leads to the release of histamine and other proinflammatory mediators that may cause the red, swollen, itchy hives commonly seen in CSU. Remibrutinib is taken twice daily with or without food, and no lab monitoring is required.
Other treatments: Antihistamines are the first-line treatment for CSU, but more than half of patients still have symptoms, even at higher doses, according to the manufacturer. Injectable treatments are available for those who don’t respond to antihistamines, but few eligible patients receive them. Prescriber information for remibrutinib is available on the Novartis website.