Argenx gets the green light to market its first treatment in the United States

Belgian-Dutch biotech Argenx announced Friday evening that it had obtained the green light from the Food and Drug Administration (FDA) for the marketing of its drug efgartigimod, marketed under the name “Vyvgart”, for the treatment of myasthenia gravis on the American market. severe generalized, autoimmune disease that causes muscle weakness.

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This is the first biotech product listed on Euronext Brussels to be approved for marketing. Authorization requests have also been made in Japan and with the European Medicines Agency with a view to placing it on the European market. Decisions are expected in the first quarter and second half of 2022 respectively.

Argenx has also entered into a partnership with Zai Lab for the development and commercialization of its treatment in China. A green light for placing on the Chinese market could come in mid-2022. FDA approval already results in a $ 25 million milestone payment to Argenx.

Analysts say efgartigimod has the potential to generate multibillion dollar revenue for Argenx, making it a “blockbuster”. This term refers to drugs that have sales of over $ 1 billion annually.


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