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ROZ-DT-QA-001 PLS 18.06.24.pdf (209.32 kB)

Rozanolixizumab in generalized myasthenia gravis: a profile of its use

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posted on 2024-07-09, 21:59 authored by Sheridan M. Hoy
Funding The preparation of this review was not supported by any external funding.
Authorship and conflict of interest 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.
Ethics approval, Consent to participate, Consent for publication, Availability of data and material, Code availability Not applicable.

Additional information about this Adis Drug Review can be found here.


Rozanolixizumab (rozanolixizumab-noli; RYSTIGGO®), a humanized IgG4 monoclonal antibody with a high affinity and specificity for human neonatal Fc receptor (FcRn; which plays a vital role in the transport, distribution and persistence of IgG), is an effective and generally well tolerated treatment option in adults with acetylcholine receptor (AChR) or muscle-specific kinase (MuSK) autoantibody-positive generalized myasthenia gravis (gMG). Administered subcutaneously once weekly for 6 weeks, with subsequent treatment cycles based on clinical evaluation, it is approved for the treatment of adults with gMG in the EU, Japan and the USA. In a multinational phase 3 study, one 6-week cycle of rozanolixizumab ≈ 7 mg/kg or ≈ 10 mg/kg improved multiple disease-related outcomes versus placebo, with the benefits sustained following repeated treatment cycles according to a pooled analysis of data from the phase 3 study and two phase 3 extension studies. While increased infection susceptibility could be a consequence of the transient reduction in IgG levels with rozanolixizumab therapy, no severe or serious infections were reported in either rozanolixizumab group in the study.

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