10 November 2023 - The CHMP positive opinion is based on the pivotal Phase 3 MycarinG study in generalised myasthenia gravis in adult patients, which demonstrated treatment with rozanolixizumab resulted in statistically significant and clinically meaningful improvements in generalised myasthenia gravis-specific outcomes compared to placebo, including everyday activities such as breathing, talking, swallowing, and being able to rise from a chair.

UCB today announced that the CHMP of the EMA has issued a positive opinion recommending granting marketing authorisation for rozanolixizumab as an add-on to standard therapy for the treatment of generalised myasthenia gravis in adult patients who are anti-acetylcholine receptor or anti-muscle-specific tyrosine kinase antibody positive.

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