The first anti-FcRn monoclonal antibody was approved by the FDA for marketing!

Text: Picking up shells

On December 17, Argenx announced that the US FDA approved VYVGART™ (efgartigimod alfa-fcab) for the treatment of adult systemic myasthenia gravis (gMG) with positive anti-acetylcholine receptor (AChR) antibodies

Efgartigimod is the first anti-FcRn monoclonal antibody approved by the FDA

Efgartigimod's approval was based on the results of the global Phase III ADAPT trial.

In addition, Argenx is also trying to expand the use of efgartigimod for five other indications, and has submitted regulatory applications for the treatment of gMG in Europe and Japan

Evaluate expects that efgartigimod will bring it $3 billion in revenue in 2026

It is worth noting that in January 2021, Zai Lab and Argenx reached an agreement to obtain the exclusive right to develop and commercialize efgartigimod in Greater China

Argenx will receive a total of US$175 million in cooperative payments, including an upfront payment of US$75 million, 568,182 additional Zai Lab shares issued at a price of US$132 per share, payment of US$75 million in clinical development costs, and A milestone payment of $25 million after efgartigimod was approved in the United States