Posted by Michael Wonder on 27 Jun 2023
UCB announces US FDA approval of Rystiggo (rozanolixizumab-noli) for the treatment of adults with generalised myasthenia gravis
27 June 2023 - US FDA approval is based on the pivotal Phase 3 MycarinG study in gMG2, a large phase 3 study which demonstrated treatment with rozanolixizumab-noli resulted in statistically significant improvements in gMG-specific outcomes, including everyday activities such as breathing, talking, swallowing, and being able to rise from a chair.
UCB today announced Rystiggo (rozanolixizumab-noli) has been approved by the US FDA for the treatment of generalised myasthenia gravis in adult patients who are anti-acetylcholine receptor or anti-muscle-specific tyrosine kinase antibody positive.
