Enzyvant's RVT-802 biologics license application accepted by the FDA and qualified for priority review

Today, The(http:// of the http://company of Enzyvant Sciences
, announcedthat it had accepted its biologic license application (BLA) for theof the research therapy RVT-802the FDA(http:// and also granted it priority review eligibilityRVT-802 is a new type of tissue-based regenerative therapy designed to treat congenital thymosy disorder in childrenThe application is expected to be approved in December 2019on the RVT-802RVT-802 is designed as a one-time regenerative therapy for immunodeficiency, designed to replicate the process of "T cells starting from bone marrow stem cells and then transferring to the thymus" that occurs in's healthy(http://and functional immune system without thymus glandsRVT-802 from the baby thymus tissue was treated and cultured and implanted in the quadriceps of the childChildren with bone marrow stem cells are transferred to implanted tissues
products (http:// and are trained to be immunized into new T-cells With the recovery of T-cell generation, the immune system can be further restored and the body's ability to fight infection 　The study RVT-802 therapy is based on the work of Professor Mary Louise Markert of Duke University 　　The BLA application for RVT-802 is based on clinical trial (http:// data that demonstrate its long-term effectiveness A total of 93 children received RVT-802, 85 of whom met the criteria for (http:// included in efficacy analysis Kaplan-Meier estimated survival rates at 76 per cent (66-84 per cent) and 75 per cent (66-83 per cent) in the first and second years after treatment, respectively For children who survived more than 12 months after treatment, their 10-year survival rate is expected to be 93% the findings were published in the New England Journal of Medicine, as well as in many other peer-reviewed scientific journals and clinical journals