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Argenx, Calliditas Hit The Ground Running After FDA Approvals

Green Lights For Vyvant and Tarpeyo

 
• By Kevin Grogan

Two European companies - the Belgian-Dutch biotech Argenx and Calliditas of Sweden - are going it alone to commercialize their just-approved rare disease therapies in the US.

eu flags
Last week was a cause for celebration for two European biotechs bagging US approvals • Source: Alamy

A good week for European biotech in the US, which began with Calliditas Therapeutics AB's Tarpeyo getting accelerated approval for immunoglobulin A nephropathy (IgAN), was rounded off by argenx N.V. getting the green light for Vyvgart in generalized myasthenia gravis (gMG).

First to the eagerly-anticipated approval by the US Food and Drug Administration of Vyvgart(efgartigimod) on 17 December for adults who are anti-acetylcholine receptor (AChR) antibody positive, a sub-group that represents 85% of the total gMG population

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