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Argenx Builds Presence As Efgartigimod Positive In Pivotal Myasthenia Study

US BLA Submission By End Of 2020

 
• By John Davis

The European biotech argenx has reported positive top-line results for its FcRn antagonist efgartigimod in generalized myasthenia gravis in the Phase III ADAPT study, and is planning to market the product itself in the US, Japan and major EU countries.

Neuromuscular_Junction
A neuromuscular junction; dysfunctional junctions are associated with myasthenia gravis • Source: Shutterstock

Top-line Phase III data from the first pivotal trial of argenx SE’s lead product, efgartigimod, show it is associated with a fast onset of action, deep responses and the potential for sustained responses in patients with myasthenia gravis, and the European biotech is working on commercialization plans for the potential first-in-class product, with approvals expected in 2021.

“We are ready to realize our 2021 vision and to make the shift to be a commercial organization,” said CEO...

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