FDA ap­proves first of two UCB myas­the­nia gravis drugs, fol­low­ing Alex­ion and ar­genx’s lead

The FDA ap­proved UCB’s gen­er­al­ized myas­the­nia gravis treat­ment Rystig­go, with the Bel­gian drug­mak­er say­ing it is the first drug to get OK’d for the two main sub­types of the rare au­toim­mune dis­ease.

UCB said Tues­day that the un­der-the-skin treat­ment, known in­ves­ti­ga­tion­al­ly as rozano­lix­izum­ab-no­li, will be com­mer­cial­ly avail­able in the third quar­ter. It fol­lows the nod last week for ar­genx’s Vyv­gart Hytru­lo in sub­cu­ta­neous form. That ther­a­py was ini­tial­ly giv­en the thumbs-up as an in­jectable in 2021.

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