Novartis has received FDA approval for its oral Bruton’s tyrosine kinase inhibitor (BTKi), Rhapsido (remibrutinib), marking a major therapeutic milestone in the treatment of chronic spontaneous urticaria (CSU), also known as chronic hives. Rhapsido is now the first and only oral targeted BTKi approved in the U.S. for adults with CSU who remain symptomatic despite standard antihistamine treatment.
The FDA’s decision is based on data from the Phase 3 REMIX-1 and REMIX-2 clinical trials, where Rhapsido demonstrated superior efficacy versus placebo. Patients taking the twice-daily oral drug experienced significant reductions in itch and hives as early as two weeks into therapy, with around one-third reaching complete relief by week 12. Notably, Rhapsido does not require lab monitoring or injections, offering a convenient new option for the estimated 1.7 million Americans living with CSU—over half of whom continue to experience symptoms despite antihistamine use.
Rhapsido works by selectively inhibiting the BTK pathway, which is involved in the release of histamine and other inflammatory mediators driving urticaria. The most common adverse reactions reported include nasopharyngitis, headache, bleeding, nausea, and abdominal pain, but Novartis describes the overall safety profile as manageable.
This approval represents a significant advance for patients and strengthens Novartis’s immunology portfolio. The company has also filed for Rhapsido’s approval in Europe, Japan, and China, with additional indications under investigation including food allergy and chronic inducible urticaria.
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