Novartis Gains FDA Approval for Oral BTK Inhibitor Remibrutinib Treating Chronic Spontaneous Urticaria

The U.S. Food and Drug Administration has approved remibrutinib, marketed as Rhapsido by Novartis, as a novel oral treatment for adults with chronic spontaneous urticaria (CSU) who do not respond adequately to H1 antihistamines. This Bruton’s tyrosine kinase (BTK) inhibitor represents the first oral targeted BTK therapy for CSU, offering a convenient alternative to injectable biologics like omalizumab. Clinical trials REMIX-1 and REMIX-2 demonstrated that remibrutinib significantly reduces symptoms such as hives and itch severity by inhibiting the BTK pathway, which decreases histamine release from mast cells. Experts highlight that remibrutinib expands therapeutic options, potentially allowing for more personalized treatment plans and addressing a significant unmet need for patients who fail to respond to standard antihistamine therapy. Its approval marks an important advancement in CSU management, providing a promising oral option alongside existing injectable treatments. Novartis, a leading healthcare company, continues to show robust financial health alongside its innovative drug development efforts.