Efgartigimod Alfa in Generalized Myasthenia Gravis: A Profile of Its Use
Declarations
Funding The preparation of this review was not supported by any external funding.
Authorship and Conflict of interest Young-A Heo is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.
Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability Not applicable
Additional information about this Adis Drug Review can be found here.
Abstract
Intravenous efgartigimod alfa (efgartigimod alfa-fcab; Vyvgart®), a first-in-class neonatal Fc receptor antagonist, is approved in several countries worldwide, including the USA and EU for the treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody positive, and in Japan for the treatment of gMG regardless of antibody status. In the double-blind, placebo-controlled phase 3 ADAPT trial in patients with gMG, efgartigimod alfa significantly and rapidly reduced disease burden and improved muscle strength and quality of life compared with placebo. The clinical benefits of efgartigimod alfa were durable and reproducible. Furthermore, in an interim analysis of the ongoing open-label phase 3 ADAPT+ extension trial, efgartigimod alfa provided consistent clinically meaningful improvements in patients gMG. Efgartigimod alfa was generally well tolerated, with most adverse events being mild to moderate in severity.
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