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Review
. 2023 Sep;83(14):1341-1347.
doi: 10.1007/s40265-023-01933-1.

Rozanolixizumab: First Approval

Sheridan M Hoy  1
Affiliations
Review

Rozanolixizumab: First Approval

Sheridan M Hoy. Drugs. 2023 Sep.

Erratum in

Abstract

Rozanolixizumab (rozanolixizumab-noli; RYSTIGGO®) is a high affinity humanized immunoglobulin G4 monoclonal antibody directed against human neonatal Fc receptor (FcRn). Administered subcutaneously, it is being developed by UCB Pharma for the treatment of autoimmune diseases and received its first approval on 27 June 2023 in the USA for the treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) or anti-muscle-specific kinase (MuSK) antibody positive. Rozanolixizumab is the first agent to be approved in the USA for both anti-AChR and anti-MuSK antibody-positive gMG. A regulatory assessment of rozanolixizumab for the treatment of gMG is currently underway in the EU and Japan. Clinical development is ongoing for the treatment of leucine-rich glioma-inactivated 1 autoimmune encephalitis, myelin oligodendrocyte glycoprotein (MOG) antibody disease and severe fibromyalgia syndrome. This article summarizes the milestones in the development of rozanolixizumab leading to this first approval for the treatment of gMG in adults who are anti-AChR or anti-MuSK antibody positive.

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Conflict of interest statement

During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Sheridan M. Hoy is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to this article and are responsible for its content.

Figures

None
Key milestones in the development of rozanolixizumab for the treatment of generalized myasthenia gravis. BLA Biologic License Application
See this image and copyright information in PMC

References

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    1. UCB Inc. UCB announces U.S. FDA approval of RYSTIGGO® (rozanolixizumab-noli) for the treatment of adults with generalized myasthenia gravis [media release]. 27 Jun 2023. https://www.ucb.com/stories-media/Press-Releases
    1. UCB Inc. RYSTIGGO® (rozanolixizumab-noli) injection, for subcutaneous use: US prescribing information. 2023. https://www.ucb-usa.com/RYSTIGGO-prescribing-information.pdf. Accessed 18 Jul 2023.

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