The FDA hit Enzyvant with a complete response letter for its regenerative tissue therapy RVT-802, an investigational drug for a rare immunodeficiency disorder.
The agency raised concerns about the manufacturing process for the product and other issues identified during an inspection of the manufacturing site.
RVT-802 is a tissue-based regenerative therapy designed to treat primary immune deficiency resulting from pediatric congenital athymia, which affects babies born without a thymus gland.
The FDA accepted the company’s BLA for RVT-802 in June and granted it several designations, including rare pediatric disease and orphan drug statuses. RVT-802 was also granted breakthrough therapy designation and was expected to be approved this month.