Ar­genx touts first-in-class win for a rare dis­ease that caus­es life-threat­en­ing mus­cle weak­ness

If you look on ar­genx’s web­site to­day, you’ll see a burst of con­fet­ti. That’s be­cause — in ad­di­tion to get­ting a new type of ther­a­py past the FDA for pa­tients with a chron­ic neu­ro­mus­cu­lar dis­ease called myas­the­nia gravis — the com­pa­ny is cel­e­brat­ing its first drug ap­proval.

Reg­u­la­tors on Fri­day gave the thumbs up to ar­genx’s ef­gar­tigi­mod, now mar­ket­ed as Vyv­gart, for pa­tients with gen­er­al­ized myas­the­nia gravis (gMG) who test pos­i­tive for the an­ti-acetyl­choline re­cep­tor (AChR) an­ti­body. CEO Tim Van Hauw­er­meiren said in a state­ment that the ap­proval trig­gers the “start of a new era for ar­genx.”

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