Enzyvant’s RVT-801, an investigational enzyme replacement therapy, was granted Rare Pediatric Disease and Fast Track designations by the FDA, the company said in a press release Thursday.
It has previously been granted orphan drug designations by the FDA and European Medicines Agency and is currently in preclinical development for Farber disease, a rare condition for which there are no approved treatments.
“These FDA designations underscore the significant need for a treatment for Farber disease and position RVT-801 to become available to patients as quickly as possible following a successful development program,” said Rachelle Jacques, CEO of Enzyvant.