5 June 2019 - RVT-802, a one-time therapy, leverages Enzyvant’s T cell generation platform designed to treat profound immunodeficiencies.
Enzyvant today announced that the U.S. FDA has accepted for filing its biologics license application for RVT-802, a novel investigational tissue-based regenerative therapy designed to treat paediatric congenital athymia, and granted priority review. Congenital athymia is a rare and deadly condition associated with complete DiGeorge anomaly, CHARGE syndrome, and FOXN1 deficiency.
At this time, the FDA is not planning to hold an Advisory Committee meeting to discuss the application, and Enzyvant anticipates a regulatory decision in December 2019.