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.
51 Articles
51 Articles
Novartis Nabs FDA Approval for First-of-Its-Kind Drug for Chronic Hives
Novartis drug Rhapsido is now approved as a second-line treatment for chronic spontaneous urticaria, a rare inflammatory skin disease. Additional clinical trials are ongoing to support potential expansion of the twice-daily pill to other immunological disorders. The post Novartis Nabs FDA Approval for First-of-Its-Kind Drug for Chronic Hives appeared first on MedCity News.
Oral Drug Wins FDA Approval for Chronic Hives
(MedPage Today) -- The FDA approved oral remibrutinib (Rhapsido) as a second-line treatment for chronic spontaneous urticaria (CSU), or chronic hives, Novartis announced on Tuesday. Indicated for adults with stubborn symptoms despite the use of...

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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