Theratechnologies Receives Positive Recommendation From the CHMP for Trogarzo® in the European Union
Theratechnologies (TSX:TH) has announced that the Committee for Medicinal Products for Human use has given a positive recommendation for approval of Trogarzo to treat multidrug resistant HIV-1. As quoted in the press release: “This is a major step in the regulatory process for the European approval of Trogarzo® and for the global development of our company, …
Theratechnologies (TSX:TH) has announced that the Committee for Medicinal Products for Human use has given a positive recommendation for approval of Trogarzo to treat multidrug resistant HIV-1.
As quoted in the press release:
“This is a major step in the regulatory process for the European approval of Trogarzo® and for the global development of our company, as Europe represents a significant mid-term growth opportunity,” said Luc Tanguay, President and Chief Executive Officer, Theratechnologies Inc.
This positive opinion will now be taken into consideration by the European Commission (EC) which will issue a final decision in the near future.
“The positive recommendation from the CHMP gives European patients reasons to hope that they could soon have access to Trogarzo®. If approved, Trogarzo® will address an important unmet medical need for patients in Europe. It will be the first antiretroviral with a new mechanism of action to be approved in Europe in the past 11 years,” said Dr. Christian Marsolais Senior Vice President and Chief Medical Officer.