Rozanolixizumab in generalized myasthenia gravis: a profile of its use

<div><strong>Declarations</strong></div> <div><strong>Funding</strong> The preparation of this review was not supported by any external funding.</div> <div><strong>Authorship and conflict of interest</strong> 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.</div> <div><strong>Ethics approval, Consent to participate, Consent for publication, Availability of data and material, Code availability</strong> Not applicable.</div> <p><br></p> <div>Additional information about this Adis Drug Review can be found <a href="http://www.springer.com/gp/adis/products-services/adis-journals-newsletters/adis-drug-reviews" target="_blank"><strong>here</strong></a>.</div> <p><br></p> <p>Abstract</p> <div>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.</div> <p><br></p> <p>© Springer Nature Switzerland AG 2024</p>