Rozanolixizumab, sold under the brand name Rystiggo, is a monoclonal antibody used for the treatment of myasthenia gravis.
[1] Rozanolixizumab is a humanized and chimeric monoclonal antibody;[4] and is a neonatal Fc receptor blocker.
[5] Rozanolixizumab was approved for medical use in the United States in June 2023,[6][7][8] and in the European Union in January 2024.
[2] Rozanolixizumab is indicated for the treatment of generalized myasthenia gravis in adults who are anti-acetylcholine receptor or anti-muscle-specific tyrosine kinase antibody positive.
[4] In November 2023, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Rystiggo, intended for the treatment of myasthenia gravis.