Novartis Announces FDA Approval of BTK Inhibitor Remibrutinib (Rhapsido) for Chronic Spontaneous Urticaria

▎Armstrong

On September 30, 2025, Novartis announced that the BTK inhibitor Remibrutinib had been approved by the FDA for marketing, indicated for the treatment of chronic spontaneous urticaria (CSU), with the trade name Rhapsido.

Remibrutinib was announced successful in the Phase III clinical trial for urticaria last year, and this time it has been successfully approved for marketing, becoming the first oral BTK inhibitor approved for the treatment of CSU. In terms of indication expansion, in addition to hidradenitis suppurativa, Novartis will also initiate a pivotal Phase III clinical trial for generalized myasthenia gravis this year.

Novartis is expected to submit the marketing application for Remibrutinib in treating CINDU in 2026, the marketing application for multiple sclerosis in 2027, and the marketing application for myasthenia gravis after 2028.

Summary

Besides Novartis, Sanofi is also focusing on expanding the application of BTK inhibitors in autoimmune diseases, simultaneously developing two BTK inhibitors. Last month, its Rizabrutinib received FDA approval for treating ITP. In China, BeiGene's Zanubrutinib is advancing to Phase III clinical trials for membranous nephropathy, while InnoCare Pharma's Orelabrutinib is progressing with clinical trials for multiple sclerosis, ITP, lupus, NMOSD, and other autoimmune indications.