Luxturna/Voretigene — FDA’s First AAV Approval
Sep 7, 2018 · 6 min read

When FDA first announced its approval of Luxturna (voretigene neparvovec-rzyl), sponsored by Spark Therapeutic, Inc in December 2017 the FDA Commissioner, Scott Gottleib made a press release about how gene therapy has become a breakthrough in the treatment of rare, intractable illnesses. It was also one of three gene therapy approvals in one incredible year for the agency, which has traditionally taken a…

