This article is more than 5 years old. Information may no longer be current.
Marketing authorization application for Luxturna filed
Click Here to Manage Email Alerts
Spark Therapeutics has submitted a marketing authorization application to the European Medicines Agency for Luxturna, its one-time gene therapy for the treatment of vision loss, according to a company press release.
Luxturna, the proposed trade name for voretigene neparvovec, would treat vision loss caused by biallelic RPE65 gene mutations in Leber congenital amaurosis or retinitis pigmentosa, the release said.
It has previously been granted orphan product designation by the EMA and is under priority review by the FDA.
“With Luxturna now in regulatory review on both sides of the Atlantic, we are building out our medical and commercial infrastructure to prepare to bring investigational Luxturna to patients in the U.S. and Europe,” John Furey, chief operating officer of Spark Therapeutics, said in the release.