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The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorization to Rhapsido (remibrutinib, Novartis), an oral pill for treating adults with chronic spontaneous urticaria who remain symptomatic despite H1 antihistamine treatment.
Remibrutinib is a selective immunosuppressant that works by inhibiting mast cell and basophil degranulation, including the release of histamine and other proinflammatory mediators. In two multicenter, randomized, double-blind, placebo-controlled phase 3 studies, Rhapsido improved itch and hives after 12 weeks of treatment compared with a placebo.
The most common side effects with Rhapsido are upper respiratory tract infections, such as nasopharyngitis and influenza.
The CHMP also recommended extending the use of Dupixent (dupilumab, Sanofi) for the treatment of chronic spontaneous urticaria in children aged 2-11 years. This is the first biologic treatment for this population of patients.
Dupixent is already approved for the treatment of atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, prurigo nodularis, eosinophil esophagitis, chronic obstructive pulmonary disease, and chronic spontaneous urticaria in adults and adolescents.
After a decision on this marketing authorization has been granted by the European Commission, detailed recommendations for the use of Dupixent will be published.
Sophie Cousins, MIPH, is a global health journalist who has reported from more than 20 countries.
