8 January 2024 - Approval of this orphan medicinal product is based on pivotal Phase 3 MycarinG study in generalised myasthenia gravis, which demonstrated that 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 European Commission has granted a marketing authorisation for Rystiggo (rozanolixizumab) on 5 January 2024 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.

Read UCB press release