Novartis' Rhapsido Receives Favorable CHMP Recommendation for Urticaria Treatment in the EU

Novartis' Remibrutinib Receives Positive Recommendation from EMA Panel

Novartis has announced that the Committee for Medicinal Products for Human Use (CHMP), part of the European Medicines Agency (EMA), has given a favorable opinion supporting the approval of remibrutinib as an oral therapy for adults with chronic spontaneous urticaria (CSU) who do not respond adequately to histamine-1 antihistamines (H1AH). The European Commission is expected to make its final decision within the next two months.

In September 2025, remibrutinib, marketed as “Rhapsido,” was approved in the United States for this patient group, becoming the first oral Bruton’s tyrosine kinase inhibitor (BTKi) authorized by the FDA for CSU. The treatment is also available in China.

Clinical Evidence Supporting Rhapsido

The CHMP’s recommendation is based on results from the REMIX-1 and REMIX-2 phase III trials, which involved patients who continued to experience symptoms despite using second-generation H1AH. These studies showed that Rhapsido led to marked reductions in itching and hives, with benefits lasting up to 52 weeks. Additionally, patients reported improved quality of life, and the safety profile was favorable, with no concerns regarding liver health.

About Rhapsido and Its Broader Potential

Rhapsido is a highly selective oral BTK inhibitor that works by limiting histamine release, thereby easing the symptoms of CSU.

Novartis is also investigating Rhapsido for other uses. The company recently shared encouraging phase III results from the RemIND study, which evaluated the drug in chronic inducible urticaria. Further research is underway to assess its effectiveness in treating other immune-related conditions, such as hidradenitis suppurativa and food allergies, expanding Novartis’ immunology portfolio.

CSU is a persistent skin disorder marked by recurring itchy hives and/or swelling (angioedema) without an identifiable external cause, affecting an estimated 40 million people globally. The condition can severely impact patients’ lives, often disturbing sleep, increasing anxiety and depression, and reducing productivity at work.

Dupixent Recommended for Expanded Use in Pediatric CSU

Regeneron Pharmaceuticals and its partner Sanofi have also received a positive opinion from the CHMP, recommending the extension of their drug Dupixent for the treatment of moderate-to-severe CSU in children. This recommendation covers patients aged 2 to 11 years who have not responded to H1AH and have not previously received anti-immunoglobulin E therapy. The European Commission’s final decision is anticipated in the coming months.

Regeneron and Sanofi collaborate globally on the development and commercialization of Dupixent. Under their agreement, Sanofi records worldwide net sales for Dupixent and Kevzara, while Regeneron receives a share of the profits or losses from global sales.

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