Theratechnologies to seek approval of Trogarzo in Europe
Theratechnologies (TSX:TH) plans to seek regulatory approval from the European Medicines Agency (EMA) for Trogarzo using efficacy and safety data from clinical trials submitted to the FDA.
“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,” Christian Marsolais, SVP and CMO of Theratechnologies, said in a statement.
Theratechnologies expects to file with the EMA around the end of the third quarter of 2018.
“I am very satisfied with the feedback received following three meetings in Europe,” said Luc Tanguay, president and CEO, of Theratechnologies. “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.”