'On track to be­come a block­buster': FDA ap­proves in­jectable form of ar­genx's au­toim­mune drug

The Dutch biotech com­pa­ny ar­genx won FDA ap­proval on Tues­day for an eas­i­er-to-ad­min­is­ter ver­sion of its au­toim­mune dis­ease drug ef­gar­tigi­mod. The new ver­sion, mar­ket­ed at Vyv­gart Hytru­lo, will be avail­able in Ju­ly.

Vyv­gart was pre­vi­ous­ly ap­proved in late 2021 as an in­tra­venous in­fu­sion for peo­ple with gen­er­al­ized myas­the­nia gravis, a con­di­tion in which a per­son’s own im­mune sys­tem er­rant­ly makes an­ti­bod­ies that at­tack their mus­cles. The dis­ease can make mov­ing, speak­ing, and swal­low­ing dif­fi­cult and be­comes life-threat­en­ing when it im­pedes breath­ing.

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