Korean Novartis recently submitted an application for domestic approval of “Rhapsido” (remibrutinib), an oral treatment for chronic spontaneous urticaria (CSU), potentially offering a new therapeutic option for patients suffering from the condition. The application was filed with the Ministry of Food and Drug Safety on January 28, 2026, according to industry sources.
Currently, patients with CSU typically begin treatment with third-generation antihistamines. When these prove ineffective, dosages are increased or immunosuppressants are considered. However, high-dose antihistamines can cause side effects such as fatigue, memory impairment, and gastrointestinal issues, while immunosuppressants carry risks including decreased immunity, diabetes, and hair loss.
Rhapsido is a BTK (Bruton’s tyrosine kinase) inhibitor, and received FDA approval in September 2025. Clinical trials, specifically the REMIX-1 and REMIX-2 Phase 3 studies, demonstrated significant improvements in itchiness, hives, and daily urticaria activity scores at week 12 compared to a placebo group in patients whose symptoms were not adequately controlled by existing antihistamines.
The development of Rhapsido represents a shift in treatment options for CSU patients who may be hesitant to undergo injectable therapies like Novartis’s existing drug, “Xolair” (omalizumab). Xolair requires administration via injection. Rhapsido, as an oral medication, offers a potentially more convenient alternative.
According to the Daily Pharm, the approval of Rhapsido is anticipated in the first half of 2026, potentially marking the first BTK inhibitor approved for CSU in South Korea. The drug’s mechanism targets the core pathophysiology of CSU by inhibiting BTK, thereby blocking the release of histamine and inflammatory mediators.
CSU is characterized by the presence of hives or redness lasting for more than six weeks without a clear cause. Approximately 50% of CSU patients do not respond to high-dose antihistamines, and fewer than 20% are considered suitable candidates for Xolair injections.
Novartis is also pursuing expanded indications for remibrutinib, including potential applications in autoimmune diseases, which could further solidify its market position. The company has also engaged in public awareness campaigns, such as the “Mandu’s Dream” campaign on Instagram, to increase awareness of CSU.
Competition in the CSU treatment market is expected to intensify with the potential approval of Rhapsido, alongside existing options like Xolair, Dupixent, and Omriclo (Celltrion’s biosimilar of Xolair).
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