European Medicines Agency Validates Marketing Authorization Application for Trogarzo

- September 14th, 2018

Theratechnologies (TSX:TH) is pleased to announce that the European Medicines Agency 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 … Continued

Theratechnologies (TSX:TH) is pleased to announce that the European Medicines Agency 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.

As quoted in the press release:

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.

“We are very pleased with the way the European file is progressing. We believe that Europe could also represent a substantial market for the drug if approved by the EMA. The market uptake in Europe could benefit from the positive reaction and prior experience with Trogarzo™ in the United States,” said Luc Tanguay, President and Chief Executive Officer, Theratechnologies Inc.

Click here to read the full press release.

Are You Aware of the FDA's Plans for 2018?

Find out what's going on in our new report
 

Leave a Reply

Your email address will not be published. Required fields are marked *