05:06:57 EDT Tue 19 Mar 2024
Enter Symbol
or Name
USA
CA



Theratechnologies Inc
Symbol TH
Shares Issued 75,033,228
Close 2018-04-23 C$ 9.38
Market Cap C$ 703,811,679
Recent Sedar Documents

Theratechnologies to seek EMA OK for Trogarzo in Europe

2018-04-24 11:08 ET - News Release

Mr. Luc Tanguay reports

THERATECHNOLOGIES TO SEEK REGULATORY APPROVAL OF TROGARZO (IBALIZUMAB) IN EUROPE

Theratechnologies Inc. will seek regulatory approval from the European Medicines Agency (EMA) for Trogarzo using efficacy and safety data from the clinical trials submitted to the U.S. Food and Drug Administration (FDA).

The decision follows meetings held last week in Europe with the rapporteur and co-rapporteur countries as well as with representatives from the EMA.

"Based on our discussions, we are satisfied that the filing of Trogarzo with the EMA can be done with the data currently available on file," said Dr. Christian Marsolais, PhD, senior vice-president and chief medical officer of Theratechnologies.

Dr. Marsolais was in Europe last week to hold three separate meetings with representatives from the Netherlands, Italy and the EMA.

Theratechnologies will now prepare the submission for regulatory approval in Europe and expects to file around the end of the third quarter of this year.

"I am very satisfied with the feedback received following the three meetings in Europe. Europe is the second-most important market after the United States. It is our hope and our goal to have this novel HIV-1 treatment made available to European patients with multidrug-resistant HIV-1 as quickly as possible," said Luc Tanguay, president and chief executive officer of Theratechnologies.

About Trogarzo (ibalizumab) injection

Trogarzo is a humanized monoclonal antibody for the treatment of multidrug-resistant HIV-1 infection. Trogarzo binds primarily to the second extracellular domain of the CD4-plus T receptor, away from major histocompatibility complex II molecule binding sites. It prevents HIV from infecting CD4-plus immune cells while preserving normal immunological function. Trogarzo was approved by the U.S. Food and Drug Administration on March 6, 2018.

About Theratechnologies Inc.

Theratechnologies is a specialty pharmaceutical company addressing unmet medical needs to promote healthy living and an improved quality of life among HIV patients.

We seek Safe Harbor.

© 2024 Canjex Publishing Ltd. All rights reserved.