Novartis' Rhapsido Gets EU Approval for CSU, Shows Promise in CINDU Phase 3 Trial

Novartis has received European Commission approval for its drug Rhapsido (remibrutinib), an oral treatment for chronic spontaneous urticaria (CSU), the Swiss drugmaker said on Monday. Rhapsido is the first oral targeted treatment approved for CSU, offering a unique approach to CSU treatment in a pill taken twice daily without any lab monitoring required.

Rhapsido is already cleared to treat CSU, in which patients suffer hives and swelling with no known cause, affecting roughly 1% of the global population.

Novartis is also on course to expand the label for Rhapsido after chalking up a win in chronic inducible urticaria (CINDU), a group of conditions affecting around 0.5% of the global population with 29 million cases worldwide, characterized by hives or swelling in response to physical stimuli. According to Novartis, Rhapsido achieves significantly higher complete response rates in the three most common forms of CINDU — symptomatic dermographism, cold urticaria, and cholinergic urticaria — compared to placebo in the phase 3 RemIND trial.

In the case of dermographism, triggers include friction or light scratching of the skin, while low temperatures — particularly cold water or wind — are the trigger in cold urticaria. Cholinergic urticaria can result from exercise, strong emotions, or bathing in hot water.

Novartis has already filed for approval of the drug for symptomatic dermographism, which is the most common form of CINDU, and will follow up with additional filings around the world — for all three forms — in the coming months. If approved, Rhapsido could become the first targeted therapy approved for CINDU, which is typically managed by avoiding triggers and the use of second-generation antihistamines, as well as off-label treatment with other drugs, including Roche's anti-IgE antibody Xolair (omalizumab). The RemIND trial enrolled 364 patients whose CINDU symptoms were not controlled using antihistamines.

The new indication could also give Novartis a niche indication where it will not have to compete with Sanofi and Regeneron's Dupixent (dupilumab), which was cleared for CSU last year. Dupixent has also been tested in previous clinical trials for CINDU, with initial results reported in cold urticaria. However, Sanofi's latest pipeline listing suggests it is now focusing on another candidate, KIT inhibitor SAR449028, which is in phase 2 testing. It also has an oral BTK drug (rilzabrutinib) in mid-stage testing for CSU.

Rhapsido was approved in the US last September and started rolling out onto the market towards the end of the year. So far, the company has not reported any sales figures, but Novartis' CEO pointed to "encouraging" take-up in CSU patients refractory to antihistamines, as well as after the failure of biologics, in the company's fourth-quarter 2025 results update. The CEO stated that Rhapsido is one of these brands that the company hopes over time could become one of the largest in Novartis' history, noting that early take-up is "right in line with some of the most successful dermatology launches."