Rozanolixizumab

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Rozanolixizumab
Monoclonal antibody
TypeWhole antibody
SourceChimeric/humanized hybrid
TargetNeonatal Fc receptor (FCGRT)
Names
Trade namesRystiggo
Other namesUCB-7665, rozanolixizumab-noli
Clinical data
Routes of
use		Subcutaneous
External links
AHFS/Drugs.comMonograph
MedlinePlusa623040
Legal
License data
Legal status
Chemical and physical data
FormulaC6462H9984N1704O2016S44
Molar mass145211.51 g·mol−1

Rozanolixizumab, sold under the brand name Rystiggo, is a medication used to treat myasthenia gravis.[3] Specifically it is used in those who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive with generalized disease.[3] It is given by gradual injection under the skin.[3] It is used with other medications.[1]

Common side effects include headache, infections, diarrhea, fever, allergic reactions, and nausea.[3] Serious side effects may include aseptic meningitis and angioedema.[3] It is a humanized monoclonal antibody; which blocks neonatal Fc receptors.[3][4]

Rozanolixizumab was approved for medical use in the United States in 2023 and Europe in 2024.[3][1] In the United States a dose costs about 10,000 to 20,000 USD as of 2024.[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.[3][6]

Dosage

It is given at a dose of 420 to 840 mg depending on a persons weight once per week for 6 weeks at a time.[3][1]

Society and culture

Names

Rozanolixizumab is the international nonproprietary name.[4]

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 treatment of myasthenia gravis.[7] The applicant for this medicinal product is UCB Pharma.[7]

References

  1. ↑ 1.0 1.1 1.2 1.3 "Rystiggo EPAR". European Medicines Agency. 22 April 2020. Archived from the original on 29 February 2024. Retrieved 18 March 2024.
  2. ↑ "Rystiggo Product information". Union Register of medicinal products. 8 January 2024. Archived from the original on 9 July 2024. Retrieved 18 March 2024.
  3. ↑ 3.0 3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.8 3.9 "Rystiggo- rozanolixizumab injection, solution". DailyMed. U.S. National Library of Medicine. 30 June 2023. Archived from the original on 29 August 2023. Retrieved 29 August 2023.
  4. ↑ 4.0 4.1 World Health Organization (2017). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 77". WHO Drug Information. 31 (1). hdl:10665/330984.
  5. ↑ "Rystiggo Prices, Coupons, Copay Cards & Patient Assistance". Drugs.com. Archived from the original on 19 June 2024. Retrieved 6 July 2024.
  6. ↑ "Drug Approval Package: Rystiggo". U.S. Food and Drug Administration (FDA). 25 July 2023. Archived from the original on 20 November 2023. Retrieved 20 November 2023.
  7. ↑ 7.0 7.1 "Rystiggo: Pending EC decision". European Medicines Agency (EMA). 10 November 2023. Archived from the original on 13 November 2023. Retrieved 5 December 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.

External links

Identifiers:
  • 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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