Novartis' Rhapsido Gets Positive CHMP Opinion for Urticaria in EU

Novartis NVS announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending marketing authorization for remibrutinib as an oral treatment for adult patients with chronic spontaneous urticaria (CSU) who have an inadequate response to histamine-1 antihistamines (H1AH). The final decision of the European Commission is expected in the coming two months.

Remibrutinib was approved in the United States under the brand name “Rhapsido” for the said patient population in September 2025, marking it the first FDA-approved oral Bruton’s tyrosine kinase inhibitor (BTKi) for CSU. The therapy is also approved in China.

CHMP Nod to NVS’ Rhapsido Based on Phase III Studies

The positive opinion by CHMP is supported by data from late-stage REMIX-1 and REMIX-2 studies on patients who remained symptomatic on second-generation H1AH. The studies demonstrated significant improvements in itch and hives, with sustained benefits through week 52 from baseline. Rhapsido also improved quality of life, while demonstrating a favorable safety profile with no liver safety concerns.

More on NVS’ Rhapsido

Rhapsido is a highly selective oral BTK inhibitor designed to reduce histamine release, thereby alleviating CSU symptoms.

Beyond CSU, Novartis is advancing Rhapsido for additional indications. The company announced positive data from the phase III RemIND study evaluating Rhapsido in chronic inducible urticaria. The drug is also being evaluated for other immune-mediated conditions like hidradenitis suppurativa and food allergies, further broadening Novartis’ immunology pipeline.

CSU is a chronic skin disease characterized by recurrent itchy hives and/or angioedema without an external trigger, affecting about 40 million people worldwide. The disease imposes a substantial burden on patients, often disrupting sleep, contributing to anxiety and depression, and impairing workplace productivity.

Regeneron Pharmaceuticals REGN and its partner Sanofi SNY announced yesterday that the CHMP of the EMA has also issued a positive opinion recommending the expanded use of their blockbuster drug, Dupixent, for treating moderate-to-severe CSU in children. The recommendation supports Dupixent’s use in CSU patients aged 2 to 11 years who have an inadequate response to histamine-1 antihistamines and who are naive to anti-immunoglobulin E therapy. A final decision of the European Commission is expected in the coming months.

Regeneron has a global strategic collaboration with Sanofi for the discovery, development and commercialization of Dupixent. Under the collaboration agreement, Sanofi records global net product sales of Dupixent and Kevzara while Regeneron records its share of profits or losses in connection with the global sales of the drugs.

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