Enzyvant resubmits BLA for pediatric congenital athymia drug

Nearly 18 months on from Enzyvant’s receipt of a Complete Response Letter (CRL) relating to its initial Biologics Licensing Application (BLA) for RVT-802, the company has filed an amended submission.

The US Food and Drug Administration (FDA) made several regulatory requests related to chemistry, manufacturing and controls in a December 2019 CRL that followed the first 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 agency under the Prescription Drug User Fee Act is October 8, 2021.