Theratechnologies Receives Positive Recommendation From the CHMP for Trogarzo® in the European Union
- Category: Antibodies
- Published on Friday, 26 July 2019 20:09
- Hits: 838
MONTREAL, Canada I July 26, 2019 I Theratechnologies Inc. (Theratechnologies) (TSX: TH) is pleased to announce that the Committee for Medicinal Products for Human use (CHMP) in Europe has given a positive recommendation for the approval of Trogarzo® (ibalizumab) for the treatment of Multidrug Resistant HIV-1.
“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.
“Our pre-launch activities in Europe have been ramping up over the past twelve months. Based on the recommendation from the CHMP, we will start implementing the next phase of our plan which will ensure that we have an optimal launch when the EMA makes its final decision known,” added Luc Tanguay.
Theratechnologies (TSX: TH) is a specialty pharmaceutical company addressing unmet medical needs by bringing to market specialized therapies for people with orphan medical conditions, including those living with HIV. Further information about Theratechnologies is available on the Company's website at www.theratech.com and on SEDAR at www.sedar.com.