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FDA approval of Vyvgart (efgartigimod alfa-fcab)in generalized myasthenia gravis .- Zai Lab and argenx.

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Last updated:20th Dec 2021
Published:19th Dec 2021
Zai Lab Limited announced that its partner argenx announced that FDA has approved Vyvgart (efgartigimod alfa-fcab) for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.

These patients represent approximately 85% of the total gMG population. With this regulatory milestone, Vyvgart is the first and only FDA-approved neonatal Fc receptor (FcRn) blocker.

The approval of Vyvgart is based on results from the global Phase III ADAPT trial, which were published in the July 2021 issue of The Lancet Neurology. The ADAPT trial met its primary endpoint, demonstrating that significantly more anti-AChR antibody positive gMG patients were responders on the MG-ADL scale following treatment with Vyvgart compared with placebo (68% vs. 30%; p<0.0001). responders were defined as having at least a two-point reduction on the mg-adl scale sustained for four or more consecutive weeks during the first treatment cycle..></0.0001).>

See-ARTICLES| VOLUME 20, ISSUE 7, P526-536, JULY 01, 2021 -"Safety, efficacy, and tolerability of efgartigimod in patients with generalised myasthenia gravis (ADAPT): a multicentre, randomised, placebo-controlled, phase III trial"; Prof James F Howard Jr, MD Vera Bril, MD, Prof Tuan Vu, MD, Chafic Karam, MD,et al. Published:July, 2021DOI:https://doi.org/10.1016/S1474-4422(21)00159-9,The Lancet Neurology.

Condition: Myasthenia Gravis
Type: drug

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