![From QSR to QMSR: Meeting FDA’s New Requirements From QSR to QMSR: Meeting FDA’s New Requirements](https://www.fdanews.com/ext/resources/Book-Covers-NEW/From-QSR-to-QMSR-500.png?height=200&t=1714569011&width=200)
Home » Enzyvant Gains Two FDA Therapy Designations for its Drug Candidate RVT-802
Enzyvant Gains Two FDA Therapy Designations for its Drug Candidate RVT-802
April 21, 2017
Enzyvant was granted an FDA regenerative medicine advanced therapy designation and a breakthrough therapy designation for its investigational therapy RVT-802.
The therapy is being developed for complete DiGeorge syndrome, which is characterized by congenital heart disease, hypoparathyroidism and athymia in pediatric patients.
Preliminary clinical results suggest a survival rate of over 70 percent for treated patients, according to the company.
In addition to these designations, RVT-802 has been granted orphan drug designation by the FDA. Enzyvant anticipates a BLA filing in the first half of 2018.
Upcoming Events
-
21Oct