Posted by Michael Wonder on 27 Apr 2021
Enzyvant resubmits biologics licence application to FDA for RVT-802 for paediatric congenital athymia
27 April 2021 - Enzyvant today announced the resubmission of the biologics licence application to the U.S. FDA for RVT-802, cultured human thymus tissue. RVT-802 is a one-time tissue-based regenerative therapy for the treatment of paediatric patients with congenital athymia.
The FDA made several regulatory requests related to Chemistry, Manufacturing and Controls in a December 2019 complete response letter that followed the initial RVT-802 BLA submission in April 2019. Enzyvant has been working since that time to address each of the FDA requests.
The expected action date provided by the FDA under the Prescription Drug User Fee Act is 8 October 2021.
