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"First-in-class" Myasthenia Gravis Therapy Receives FDA Approval

 Last Update: 2021-12-26
 Source: Internet
 Author: User

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A few days ago, argenx announced that the US FDA approved the "first-in-class" therapy Vyvgart (efgartigimod alfa-fcab) for the treatment of anti-acetylcholine receptor (AChR) antibody-positive systemic myasthenia gravis (gMG) adult patients

Myasthenia gravis is a rare chronic autoimmune disease

Vyvgart is a "first-in-class" therapy targeting FcRn, designed to reduce pathogenic IgG antibodies and block the IgG recycling process

This approval is based on the results of the global Phase 3 clinical trial ADAPT, which was published in The Lancet Neurology in July this year

Reference materials:

[1] argenx Announces US Food and Drug Administration (FDA) Approval of VYVGART™ (efgartigimod alfa-fcab) in Generalized Myasthenia Gravis.

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