Enzyvant Reports FDA’s Acceptance of BLA for RVT-802 to Treat Pediatric Congenital Athymia

Enzyvant Reports FDA’s Acceptance of BLA for RVT-802 to Treat Pediatric Congenital Athymia

Shots:

  • The BLA submission is based on study assessing RVT-802 in 93 patients with Pediatric Congenital Athymia
  • The study resulted in survival rates of (76%, 75%) as estimated with Kaplan-Meier @1,2 yrs. and for the patients surviving 12 mos. post-treatment has a possibility of 93% probability of surviving 10 years post-treatment
  • RVT-802 is a one-time tissue-based regenerative therapy targeted for pediatric congenital athymia and has also received FDA’s PR for same. In 2016, Enzyvant entered into an exclusive WW license agreement with Duke University to develop RVT-802

Click here to read full press release/ article | Ref: Enzyvant | Image: ID Works Global