The amount of circulating IgG decreases and therefore prevents the acetylcholine receptors from being degraded by the autoantibodies that are responsible for the myasthenia gravis. Pharmacokinetics
The drug is mainly metabolized via proteolytic enzymes. The termination half-life of Efgartigimod alfa is 80 to 120 hours. Side effects
Side effects of efgartigimod alfa include respiratory tract infections, headache, urinary tract infection, numbness and tingling and muscle pain. Society and culture
Legal status
The U.S. Food and Drug Administration (FDA) granted the application for efgartigimod alfa fast track and orphan drug designations. The FDA granted the approval of Vyvgart to Argenx BV.On 23 June 2022, 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 Vyvgart, intended for the treatment of anti‑acetylcholine receptor (AChR) antibody positive generalized myasthenia gravis. The applicant for this medicinal product is Argenx. Efgartigimod alfa was approved for medical use in the European Union in August 2022. Names
Efgartigimod alfa is the international nonproprietary name (INN). References
This article incorporates public domain material from the United States Department of Health and Human Services. Further reading
Howard JF, Bril V, Vu T, Karam C, Peric S, Margania T,  et al. (July 2021). "Safety, efficacy, and tolerability of efgartigimod in patients with generalised myasthenia gravis (ADAPT): a multicentre, randomised, placebo-controlled, phase 3 trial". Lancet Neurol. 20 (7): 526–536. doi:10.1016/S1474-4422(21)00159-9. hdl:10067/1859580151162165141. PMID 34146511. S2CID 235456637. External links
"Efgartigimod alfa". Drug Information Portal. U.S. National Library of Medicine.
Clinical trial number NCT03669588 for "An Efficacy and Safety Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness (ADAPT)" at ClinicalTrials.gov