Rozanolixizumab Explained

Type:mab
Mab Type:mab
Source:xizu
Target:Neonatal Fc receptor (FCGRT)
Tradename:Rystiggo
Dailymedid:Rozanolixizumab
Routes Of Administration:Subcutaneous
Atc Prefix:L04
Atc Suffix:AG16
Legal Us:Rx-only
Legal Us Comment:[1]
Legal Eu:Rx-only
Legal Eu Comment:[2] [3]
Cas Number:1584645-37-3
Drugbank:DB14919
Unii:P7186074QC
Kegg:D12182
Synonyms:UCB-7665, rozanolixizumab-noli
C:6462
H:9984
N:1704
O:2016
S:44

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;[4] and is a neonatal Fc receptor blocker.

The most common adverse reactions include headache, infections, diarrhea, pyrexia, hypersensitivity reactions, and nausea.[5]

Rozanolixizumab was approved for medical use in the United States in June 2023.[6] [7] [8]

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.[9]

Society and culture

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.[10]

Notes and References

  1. Web site: Rystiggo- rozanolixizumab injection, solution . DailyMed . U.S. National Library of Medicine . 30 June 2023 . 29 August 2023 . 29 August 2023 . https://web.archive.org/web/20230829050720/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3c0eb8c2-c042-4954-b451-3baa77f5e6d1 . live .
  2. Web site: Rystiggo EPAR . European Medicines Agency . 22 April 2020 . 18 March 2024.
  3. Web site: Rystiggo Product information . Union Register of medicinal products . 8 January 2024 . 18 March 2024.
  4. ((World Health Organization)) . International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 77 . WHO Drug Information . 31 . 1 . 2017 . 10665/330984 . free . World Health Organization .
  5. Web site: FDA Roundup: June 27, 2023 . U.S. Food and Drug Administration (FDA) . 27 June 2023 . 28 June 2023 . 27 June 2023 . https://web.archive.org/web/20230627230956/https://www.fda.gov/news-events/press-announcements/fda-roundup-june-27-2023 . live .
  6. Web site: Novel Drug Approvals for 2023 . U.S. Food and Drug Administration (FDA) . 28 June 2023 . 28 June 2023 . 21 January 2023 . https://web.archive.org/web/20230121035617/https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2023 . live .
  7. UCB announces U.S. FDA approval of Rystiggo (rozanolixizumab-noli) for the treatment of adults with generalized myasthenia gravis . UCB . PR Newswire . 27 June 2023 . 28 June 2023 . 28 June 2023 . https://web.archive.org/web/20230628045311/https://www.prnewswire.com/news-releases/ucb-announces-us-fda-approval-of-rystiggo-rozanolixizumab-noli-for-the-treatment-of-adults-with-generalized-myasthenia-gravis-301864023.html . live .
  8. Hoy SM . Correction to: Rozanolixizumab: First Approval . Drugs . 83 . 16 . 1569 . November 2023 . 37861882 . 10624700 . 10.1007/s40265-023-01960-y .
  9. Web site: Drug Approval Package: Rystiggo . U.S. Food and Drug Administration (FDA) . 25 July 2023 . 20 November 2023 . 20 November 2023 . https://web.archive.org/web/20231120061829/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761286Orig1s000TOC.cfm . live .
  10. Web site: Rystiggo: Pending EC decision . European Medicines Agency (EMA) . 10 November 2023 . 5 December 2023 . 13 November 2023 . https://web.archive.org/web/20231113193556/https://www.ema.europa.eu/en/medicines/human/summaries-opinion/rystiggo . live . Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.

This article is licensed under the GNU Free Documentation License. It uses material from the Wikipedia article "Rozanolixizumab".

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