Af­ter three decades and a sur­prise re­jec­tion, first treat­ment for ba­bies born with­out a thy­mus se­cures FDA ap­proval

Sum­i­to­vant Bio­phar­ma’s sub­sidiary En­zy­vant late Fri­day won ap­proval for its first treat­ment, which is al­so the first promis­ing treat­ment for ba­bies with­out a thy­mus, an or­gan that plays a cru­cial role in help­ing to fight in­fec­tions.

The treat­ment, known as Rethymic (al­lo­gene­ic processed thy­mus tis­sue-agdc), is a one-time re­gen­er­a­tive ther­a­py for what’s for­mal­ly known as con­gen­i­tal athymia. En­zy­vant, which li­censed the drug from Duke Uni­ver­si­ty in 2017, said that usu­al­ly about 20 ba­bies per year in the US are born with the con­di­tion, and many of­ten die from in­fec­tions or au­toim­mune man­i­fes­ta­tions by age two or three.

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