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Oral Drug Wins FDA Approval for Chronic Hives

Rhapsido, an oral Bruton's tyrosine kinase inhibitor, significantly improved symptom control in nearly 50% of chronic spontaneous urticaria patients in Phase III trials, offering a non-injectable option.

  • Rhapsido® received FDA approval as an oral treatment for adults with chronic spontaneous urticaria , announced by Novartis.
  • Rhapsido is an oral pill taken twice daily, eliminating the need for injections or lab monitoring, which offers convenience for patients.
  • This treatment works by inhibiting the release of histamine and targets BTK, providing a new approach to treat CSU.
  • The approval is based on results from Phase III REMIX-1 and REMIX-2 clinical trials involving patients who were still symptomatic on H1 antihistamines.
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Chatham Star TribuneChatham Star Tribune
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Novartis receives FDA approval for Rhapsido® (remibrutinib), the only oral, targeted BTKi treatment for chronic spontaneous urticaria (CSU)

Rhapsido helps to inhibit release of histamine and proinflammatory mediators by targeting BTK, offering unique approach to CSU treatment 1

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Globe Newswire broke the news in on Tuesday, September 30, 2025.
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