Posted by Michael Wonder on 21 Apr 2023
GenSight Biologics withdraws its EMA application for Lumevoq
20 April 2023 - GenSight Biologics today announces that the Committee for Advanced Therapies (CAT) of the CHMP of the EMA assessed the data presented during the oral explanation on Lumevoq European regulatory dossier.
Following interactions with the CAT indicating that the data provided thus far would not be sufficient to support a positive opinion of the marketing authorisation of Lumevoq by the EMA, GenSight decided to withdraw its application ahead of a final opinion by the CAT.
