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Efgartigimod Approved for Myasthenia Gravis

December 17, 2021 medscape news
FDA has approved efgartigimod (Vyvgart, argenx), a first-in-class, targeted therapy for adults with generalized myasthenia gravis (gMG) who test positive for the antiacetylcholine receptor (AChR) antibody.   

This approval represents "an important step in providing a novel therapy option for patients and underscores the agency's commitment to help make new treatment options available for people living with rare diseases,"    The rare and chronic autoimmune neuromuscular disorder of gMG causes debilitating and potentially life-threatening muscle weakness and significantly impaired independence and quality of life.   Most patients with gMG have immunoglobulin G (IgG) antibodies, which are most often directed against skeletal muscle nicotinic acetylcholine receptors.  

"Effective, Well-Tolerated"  Efgartigimod is an antibody fragment designed to reduce pathogenic IgG antibodies and block the IgG recycling process in patients with gMG.  The novel agent binds to the neonatal Fc receptor (FcRn), which is widely expressed throughout the body and plays a central role in rescuing IgG antibodies from degradation. Blocking FcRn reduces IgG antibody levels.


新药Efgartigimod (Vyvgart) 获批用于治疗重症肌无力症
FDA批准了Efgartigimod (Vyvgart, argenx),一种针对全身性肌无力(gMG)患者的突破性治疗。药物靶向乙酰胆碱受体(AChR)抗体。  这一批准 "为患者提供新型突破性治疗,并帮助罕见疾病患者获得新治疗选择"。全身性肌无力(gMG)这种罕见的慢性自身免疫性神经肌肉疾病导致患者身体虚弱,并危及生命; 患者独立性和生活质量明显受损。大多数身性肌无力(gMG)患者都有免疫球蛋白G(IgG)抗体,这些抗体针对是骨骼肌烟碱受体。   
Efgartigimod是一种抗体片段,旨在减少致病性IgG抗体,阻断患者的IgG循环过程。 这种新型药物结合胎型Fc受体(FcRn,  胎型Fc受体在全身广泛表达并阻断IgG抗体降解),阻断FcRn,降低烟碱受体IgG抗体水平。药物有效,耐受性好。。药物有效,耐受性好。 这种新型药剂与胎型Fc受体(FcRn)结合,FcRn在全身广泛表达,在挽救IgG抗体的降解过程中起着核心作用。阻断FcRn可降低IgG抗体水平。药物有效,耐受性好。

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