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# Enzyvant Resubmits BLA for Pediatric Congenital Athymia
- URL: https://www.fdaweb.com/enzyvant-resubmits-bla-for-pediatric-congenital-athymia/
- Published: 2021-04-27T12:00:00.000Z
- Updated: 2026-09-14T16:56:38.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5149193

Enzyvanthas resubmitted a BLA for RVT-802 (cultured human thymus tissue), a tissue-based regenerative therapy designed to treat pediatric congenital athymia, a rare and deadly condition associated with complete DiGeorge anomaly, Charge syndrome, and FoxN1 deficiency, according to the company. The submission addresses a 12/2019 Complete Response Letter and FDA requests related to chemistry, manufacturing and controls information. The agency set a review action target date of 10/8.

Children with congenital athymia are born without a thymus, resulting in a severe immunodeficiency due to the inability to produce normally functioning T cells, which defend against infection and regulate essential processes in the immune system, Enzyvant says. RVT-802 works, it says, by stimulating the body’s production of naive, immunocompetent T cells, with the goal of bolstering the immune system and restoring the body’s ability to fight infection.

RVT-802 is derived from infant thymus tissue, and it is processed and cultured prior to implantation into a patient’s quadricep muscle, the company says “The patient’s bone marrow stem cells migrate to the implanted tissue product, where they are trained to become naïve, immunocompetent T cells,” it says. “With the renewed ability to generate T cells, immune system function can be restored.”