Theratechnologies to seek regulatory approval of Trogarzo™ (ibalizumab) in Europe based on efficacy and safety data used for FDA approval
MONTREAL, April 24, 2018 — Theratechnologies Inc. (Theratechnologies) today announced that it 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 Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer, Theratechnologies Inc.
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 expect 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, Theratechnologies Inc.
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+ T receptor, away from major histocompatibility complex II molecule binding sites. It prevents HIV from infecting CD4+ immune cells while preserving normal immunological function.
TrogarzoTM was approved by the FDA on March 6, 2018.
Theratechnologies is a specialty pharmaceutical company addressing unmet medical needs to promote healthy living and an improved quality of life among HIV patients. Further information about Theratechnologies is available on the Company’s website at www.theratech.com and on SEDAR at www.sedar.com.