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Rozanolixizumab
Monoclonal antibody medication From Wikipedia, the free encyclopedia
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Rozanolixizumab, sold under the brand name Rystiggo, is a monoclonal antibody used for the treatment of myasthenia gravis.[3] Rozanolixizumab is a humanized and chimeric monoclonal antibody;[6] and is a neonatal Fc receptor blocker.[3][6]
The most common adverse reactions include headache, infections, diarrhea, pyrexia, hypersensitivity reactions, and nausea.[7]
Rozanolixizumab was approved for medical use in the United States in June 2023,[8][9][10] and in the European Union in January 2024.[4]
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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.[3][11]
Society and culture
Names
Rozanolixizumab is the international nonproprietary name.[6]
Legal status
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.[12] The applicant for this medicinal product is UCB Pharma.[12] Rozanolixizumab was approved for medical use in the European Union in January 2024.[4][5]
References
External links
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