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Novartis receives FDA approval for Rhapsido® (remibrutinib), the only oral, targeted BTKi treatment for chronic spontaneous urticaria (CSU)
Novartis announced today that Rhapsido® (remibrutinib) received US Food and Drug Administration (FDA) approval as an oral treatment for adult patients with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment. Rhapsido is a pill taken twice daily and does not require injections or lab monitoring. It is the first FDA-approved Bruton's tyrosine kinase inhibitor (BTKi) for CSU. Rhapsido helps to inhibit the release of histamine and other proinflammatory medi
About this update from Novartis Ag
[{"type":"list","items":[{"val":[{"type":"text","content":"Rhapsido helps to inhibit release of histamine and proinflammatory mediators by targeting BTK, offering unique approach to CSU treatment 1","length":138,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":138,"olType":false},{"type":"list","items":[{"val":[{"type":"text","content":" Well-controlled disease observed as fast as two weeks, with demonstrated safety profile that requires no lab monitoring 1","length":126,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":126,"olType":false},{"type":"list","items":[{"val":[{"type":"text","content":"1.7 million people in US live with CSU; more than half remain symptomatic despite increasing doses of antihistamines 2,3","length":120,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":120,"olType":false},{"type":"list","items":[{"val":[{"type":"text","content":"Remibrutinib also in clinical development for chronic inducible urticaria, food allergy, and hidradenitis suppurativa, expanding Novartis Immunology portfolio","length":161,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":161,"olType":false},{"type":"text","content":"EAST HANOVER, N.J., Sept. 30, 2025 /PRNewswire/ -- Novartis announced today that Rhapsido® (remibrutinib) received US Food and Drug Administration (FDA) approval as an oral treatment for adult patients with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment. Rhapsido is a pill taken twice daily and does not require injections or lab monitoring. It is the first FDA-approved Bruton's tyrosine kinase inhibitor (BTKi) for CSU. Rhapsido helps to inhibit the release of histamine and other proinflammatory mediators by targeting BTK, offering a unique approach to CSU treatment.1","length":624,"tagName":"p"},{"type":"text","content":""CSU is a serious disease that can cause debilitating symptoms and unpredictable flares. It's difficult to diagnose and manage," said Mark Lebwohl, MD, Dean for Clinical Therapeutics at the Icahn School of Medicine at Mount Sinai and member of the steering committee for the remibrutinib REMIX Phase III clinical trial program. "Remibrutinib represents a new way of treating CSU. By blocking the activity of BTK, remibrutinib stops a key pathway of the immune response in CSU. This is an exciting new option ...