Novartis received approval from the Food and Drug Administration for Rhapsido (remibrutinib), an oral treatment for adults with chronic spontaneous urticaria.
Rhapsido is the first Bruton’s tyrosine kinase inhibitor approved for the condition, according to a Sept. 30 news release. The pill is taken twice daily and does not require lab monitoring. It is intended for patients who remain symptomatic despite antihistamine therapy.
An estimated 1.7 million people in the U.S. live with chronic spontaneous urticaria, and more than half continue to experience symptoms with antihistamines. Clinical trial data showed some patients achieved well-controlled disease within two weeks of starting treatment, and about one-third had complete absence of hives and itch by week 12.
The approval is supported by phase 3 REMIX-1 and REMIX-2 studies, which found remibrutinib improved itch, hives and weekly urticaria activity scores compared to placebo.
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