Posted by Michael Wonder on 30 Aug 2018
Theratechnologies files marketing authorisation application for Trogarzo in Europe
28 August 2018 - Theratechnologies is pleased to announce that the application for marketing authorization of Trogarzo (ibalizumab) was filed with the EMA through its centralized procedure.
Theratechnologies seeks to obtain approval for ibalizumab for the treatment of multi-drug resistant human immunodeficiency virus-1 in the European Union.
The EMA has until mid September to confirm whether the application is complete, in which case, it will initiate the review of Trogarzo under the accelerated assessment procedure.
