The FDA has approved Rhapsido (remibrutinib), an oral treatment for adult patients with chronic spontaneous urticaria (CSU), according to a news release from drug manufacturer, Novartis.

Rhapsido is the first and only Bruton’s tyrosine kinase (BTK) inhibitor approved for CSU. It works by inhibiting the BTK protein, which is thought to be the cause of CSU flares. Flares can last for hours and are characterized by red, swollen and itchy hives.

During a CSU flare, the immune system becomes overactive, activated by an allergic reaction or autoimmune response. Specifically, immune cells called mast cells and basophils activate the BTK protein.

CSU affects approximately 1.7 million people in the United States, and more than half remain symptomatic despite increasing doses of antihistamines.

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