Spark Therapeutics (ONCE), a commercial gene therapy company, announced Friday that the European Commission has granted marketing authorization for LUXTURNA (voretigene neparvovec).
Source: www.rttnews.com
Spark Therapeutics, a commercial gene therapy company, has been granted marketing authorization for LUXTURNA (voretigene neparvovec) by the European Commission. LUXTURNA is a one-time gene therapy for the treatment of adult and pediatric patients with vision loss due to inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations, and who have sufficient viable retinal cells. Apart from being valid in all 28-member states of the EU, it has received approval in Iceland, Liechtenstein and Norway. This is first gene therapy for a genetic disease that has received regulatory approval in both the U.S. and EU.
