Novartis receives positive CHMP opinion for remibrutinib in chronic spontaneous urticaria (CSU)
Basel, February 27, 2026 – Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization for remibrutinib. The opinion supports its use as an oral treatment for chronic spontaneous urticaria (CSU) in adult patients with inadequate response to H1‑antihistamine treatment. “The introduction of remibrutinib represents a major advancement, providing clinicians with an oral Bruton's tyrosine kinase inhibitor (BTKi) treatment, with improvements in symptoms observed as early as Week 1,” said Prof. Dr. med. Martin Metz, Deputy Director, Institute of Allergology, Charité Universitätsmedizin Berlin. “CSU continues to impose a substantial unmet medical need, as many patients struggle to achieve adequate disease control with currently available therapies.” The positive CHMP opinion is supported by results from the pivotal REMIX-1 and REMIX-2 Phase III trials. Remibrutinib showed improvements in itch and hives as early as Week 1, with benefits sustained through Week 521. Improvements in quality of life and sleep were also observed early in treatment 1. Remibrutinib was well tolerated and demonstrated a favorable safety profile, including no liver safety concerns across both studies through Week 521. “People living with CSU often endure years of frustration, and difficulty being taken seriously. For many, the unpredictable itch flare‑ups can make it hard to sleep, focus on daily responsibilities, or even perform their jobs at times,” said Tonya Winders, President and CEO, Global Allergy & Airways Patient Platform (GAAPP). “The arrival of a new oral treatment option brings us one step closer to ensuring that every person has the opportunity to live fully again.” “Today's positive CHMP opinion is an important step towards addressing the significant unmet needs of adults living with CSU in Europe,” said Patrick Horber, M.D., President, International, Novartis. “We will continue to collaborate with regulatory authorities globally to make this important medicine, discovered and developed by Novartis, available to patients who need it most.” Following the CHMP recommendation for approval, the European Commission (EC) is expected to issue a final decision within approximately two months. About remibrutinib Remibrutinib is a highly selective, oral BTK inhibitor that blocks the BTK pathway involved in the release of histamine, a key driver of itchy hives (wheals) and swelling5-7. By reducing histamine release, remibrutinib helps relieve the symptoms of chronic spontaneous urticaria (CSU)8,9. In the US and China, remibrutinib is approved for the treatment of adult patients with CSU who have an inadequate response to H1-antihistamines, under the brand name Rhapsido ® . Remibrutinib has shown positive topline results in chronic inducible urticaria (CIndU) across the three most prevalent subtypes in the pivotal Phase III RemIND trial. It is also being investigated in other immune-mediated conditions, such as hidradenitis suppurativa (HS) and food allergy, in addition to other indications in the company's Neuroscience portfolio10 - 14.
Feb 27, 2026 | www.globenewswire.com
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