Rozanolixizumab

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;[2] and is a neonatal Fc receptor blocker.[1][2]

Rozanolixizumab
Monoclonal antibody
TypeWhole antibody
SourceChimeric/humanized hybrid
TargetNeonatal Fc receptor (FCGRT)
Clinical data
Trade namesRystiggo
Other namesUCB-7665, rozanolixizumab-noli
License data
Routes of
administration		Subcutaneous
ATC code
  • None
Legal status
Legal status
Identifiers
CAS Number
DrugBank
UNII
KEGG
Chemical and physical data
FormulaC6462H9984N1704O2016S44
Molar mass145211.51 g·mol−1

The most common adverse reactions include headache, infections, diarrhea, pyrexia, hypersensitivity reactions, and nausea.[3]

Rozanolixizumab was approved for medical use in the United States in June 2023.[4][5]

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.[1][6]

Society and culture

Names

Rozanolixizumab is the international nonproprietary name.[2]

References
  1. "Rystiggo- rozanolixizumab injection, solution". DailyMed. 30 June 2023. Retrieved 29 August 2023.
  2. World Health Organization (2017). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 77". WHO Drug Information. 31 (1). hdl:10665/330984.
  3. "FDA Roundup: June 27, 2023". U.S. Food and Drug Administration. 27 June 2023. Retrieved 28 June 2023. Public Domain This article incorporates text from this source, which is in the public domain.
  4. "Novel Drug Approvals for 2023". U.S. Food and Drug Administration (FDA). 28 June 2023. Retrieved 28 June 2023.
  5. "UCB announces U.S. FDA approval of Rystiggo (rozanolixizumab-noli) for the treatment of adults with generalized myasthenia gravis" (Press release). UCB. 27 June 2023. Retrieved 28 June 2023 – via PR Newswire.
  6. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761286Orig1s000ltr.pdf Public Domain This article incorporates text from this source, which is in the public domain.
  • Clinical trial number NCT03971422 for "A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis" at ClinicalTrials.gov


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