Rozanolixizumab

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.

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.

Names
Rozanolixizumab is the international nonproprietary name.

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. The applicant for this medicinal product is UCB Pharma.