Rozanolixizumab, sold under the brand name Rystiggo, is a monoclonal antibody used for the treatment of myasthenia gravis. Rozanolixizumab is a humanized and chimeric monoclonal antibody; and is a neonatal Fc receptor blocker.
The most common adverse reactions include headache, infections, diarrhea, pyrexia, hypersensitivity reactions, and nausea.
Rozanolixizumab was approved for medical use in the United States in June 2023, and in the European Union in January 2024.
Medical uses 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.
Society and culture Legal status In November 2023, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Rystiggo, intended for the treatment of myasthenia gravis. The applicant for this medicinal product is UCB Pharma. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. Rozanolixizumab was approved for medical use in the European Union in January 2024.
Names Rozanolixizumab is the international nonproprietary name.
Rozanolixizumab is sold under the brand name Rystiggo.
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