European Medicines Agency Validates Marketing Authorization Application for Trogarzo
TaiMed marketing partner, Theratechnologies Inc. is pleased to announce that the European Medicines Agency ("EMA") has confirmed the validity of the marketing authorization application for Trogarzo (ibalizumab) filed on August 28, 2018. The validation confirms the submission is complete, and begins the EMA's centralized review process. As a result, the start of procedure date has been set to September 13, 2018.
The EMA will review the application for Trogarzo under the accelerated assessment procedure.
The accelerated assessment procedure, which was granted in an earlier decision from the EMA, reduces the timeframe for a recommendation by the EMA to 150 review days from 210 review days for the normal procedure.
Theratechnologies seeks to obtain approval for Trogarzo for the treatment of multidrug resistant Human Immunodeficiency Virus-1 (MDR HIV-1) in the European Union.
The application is based on the same clinical trial data that was reviewed by the FDA to grant marketing authorization of Trogarzo in the United States.