Posted by Michael Wonder on 03 Nov 2020
GenSight Biologics reports validation of Lumevoq marketing authorisation application by European Medicines Agency
3 November 2020 - GenSight Biologics today reported that the Lumevoq marketing authorisation application passed the validation checks required for submissions to the European Medicines Agency, triggering the official start of the application review procedure.
The application for use of Lumevoq gene therapy to treat vision loss in patients with Leber hereditary optic neuropathy due to a mutated ND4 mitochondrial gene was submitted in September, and the procedure was formally initiated on 29 October.
