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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