Posted by Michael Wonder on 01 Aug 2018
EMA confirms accelerated assessment procedure for Trogarzo
31 July 2018 - Theratechnologies is pleased to announce that the CHMP of the EMA will review the application for marketing authorisation of Trogarzo (ibalizumab-uiyk) injection under the accelerated assessment procedure.
The accelerated assessment procedure reduces the timeframe for a recommendation by the CHMP to 150 review days from 210 review days for the normal procedure.
