Novartis' Chronic Spontaneous Urticaria Treatment, Rhapsido (Remibrutinib), Receives EMA Approval in Europe
Background on the Approval of Europe's First Oral BTK Inhibitor
The European Commission (EC) has granted final approval for Novartis' new drug, Rhapsido (Remibrutinib), for the treatment of Chronic Spontaneous Urticaria (CSU) on April 23, 2026. This approval is for adult patients whose condition is not adequately controlled by the existing standard treatment of H1 antihistamines. Rhapsido works by highly selectively and reversibly inhibiting Bruton's Tyrosine Kinase (BTK), a key enzyme involved in the disease. Previously, patients in this category had to rely on Xolair, a biologic agent requiring periodic injections. This approval provides the first oral targeted treatment option that can be taken without regular blood tests for monitoring.
Confirmed Efficacy Through Phase 3 Clinical Data
The approval of Rhapsido is based on robust efficacy and safety data from the global Phase 3 trials, REMIX-1 and REMIX-2. In the REMIX-1 trial, at week 12, the Rhapsido group showed a reduction of -20.0 points in the Weekly Urticaria Activity Score (UAS7) compared to baseline, while the placebo group showed a reduction of -13.8 points. In the REMIX-2 trial, the reduction was -19.4 points for the Rhapsido group and -11.7 points for the placebo group, demonstrating superiority over placebo (p<0.0001). Furthermore, rapid relief of itching and hives was observed within one week of treatment, and the efficacy was sustained up to 52 weeks. No clinically significant hepatotoxicity or adverse reactions were observed, ensuring long-term safety.
Analysis of Market Disruption of Xolair's Monopoly and Competitive Landscape
The European launch of Rhapsido will disrupt the monopoly of Xolair (Omalizumab), which has been co-marketed by Novartis and Roche. Sanofi and Regeneron are currently seeking approval for their biologic agent, Dupixent (Dupilumab), for the treatment of CSU, and Roche is conducting a Phase 3 trial of another oral BTK inhibitor, Fenebrutinib. Among these, Rhapsido is expected to rapidly capture the existing Xolair patient base, who previously found hospital visits inconvenient, due to its high safety profile and the convenience of not requiring monitoring.
Market Size Forecast and Reimbursement Challenges
The global market for chronic spontaneous urticaria is estimated at approximately $2 billion in 2025 across the major 7 countries (7MM) and is projected to grow at a compound annual growth rate of 10-16% to reach over $7.5 billion by 2034. Novartis plans to expand the indications for Rhapsido to include various other types of inducible urticaria, leveraging the approvals from the US FDA and European EC to establish Rhapsido as a blockbuster drug with peak annual sales of several billion dollars. However, in the European market, securing rapid reimbursement through price negotiations and health economic evaluations in each country is the biggest challenge for commercial success.
This European EMA approval signifies the commercialization of the first oral BTK inhibitor (Rhapsido) for the treatment of Chronic Spontaneous Urticaria (CSU), improving patient convenience and disrupting the market dominance of Xolair, the only existing biologic agent. Novartis aims to capture the market, which is projected to grow from approximately $2 billion in 2025 to $7.5 billion by 2034, with a compound annual growth rate of 10-16%, by leveraging the strong efficacy demonstrated in the Phase 3 REMIX-1/2 trials (with a maximum UAS7 score reduction of -20.0 points at week 12). Competition from Regeneron and Sanofi's Dupixent and Roche's Fenebrutinib is expected, making rapid reimbursement in each country crucial for initial market penetration. From a research perspective, the drug has demonstrated a differentiated safety profile with minimal hepatotoxicity concerns and no need for periodic monitoring, opening new possibilities in the field of immune therapy. In the long term, if the target indications for Rhapsido are successfully expanded to include various types of inducible urticaria, the potential for Novartis to achieve its projected peak annual sales of several billion dollars will increase.
Source: EMA (ema)