MONTREAL, Canada I September 26, 2019 I Theratechnologies Inc. (Theratechnologies) (TSX: TH) is pleased to announce that Trogarzo® (ibalizumab) was approved today by the European Commission.
“The approval of Trogarzo® by the European Commission represents a historical milestone for Theratechnologies as it becomes our first product ever approved in that territory. We have been getting ready for this moment and we will initiate our launch plan to introduce Trogarzo® sequentially on a country-by-country basis as we obtain public reimbursement. Already, we are recording sales in Europe through early access programs, which shows that there is already a high level of interest for our unique HIV treatment,” said Luc Tanguay, President and CEO, Theratechnologies Inc.
“Europe is the second largest pharmaceutical market in the world and the approval of Trogarzo® represents a tremendous opportunity for Theratechnologies. I am also very proud to know that patients in Europe can now look forward to having access to an innovative, safe and effective treatment to help them get to undetectable levels of HIV,” added Luc Tanguay.
About Trogarzo® (Europe)
Trogarzo® is a CD4-directed post-attachment HIV-1 inhibitor. Trogarzo®, in combination with other antiretroviral(s), is indicated for the treatment of adults infected with multidrug resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive antiviral regimen.
Before you receive Trogarzo®, ask your doctor for advice if you are pregnant or plan to become pregnant as it is not known if Trogarzo® may harm your unborn baby. Women who are HIV-positive must not breast feed because HIV infection can be passed on to the baby in breast milk. It is not known if Trogarzo® passes into breast milk.
Talk to your doctor or nurse straight away if you get any of the following serious side effects:
- Signs of a new infection, changes in your immune system, can happen when you start using HIV medicines. Your immune system might get stronger and begin to fight infections that have been hidden in your body for a long time (this is called ‘immune reconstitution inflammatory syndrome’). Look out for new signs of infection after receiving Trogarzo®; these can be different from person to person depending on the type of infection that was hidden and might include fever, headache, difficulty breathing, stomach ache, coughing and swollen glands (lumps and bumps on your body, neck, armpit or groin).
- Allergic reaction (hypersensivity).
The most frequently reported adverse reactions of Trogarzo® include: rash, diarrhea, dizziness, headache, nausea, fatigue and vomiting. These are not all the possible side effects of Trogarzo®.
About Theratechnologies
Theratechnologies (TSX: TH) is a commercial-stage biopharmaceutical 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.
SOURCE: Theratechnologies
Post Views: 33
MONTREAL, Canada I September 26, 2019 I Theratechnologies Inc. (Theratechnologies) (TSX: TH) is pleased to announce that Trogarzo® (ibalizumab) was approved today by the European Commission.
“The approval of Trogarzo® by the European Commission represents a historical milestone for Theratechnologies as it becomes our first product ever approved in that territory. We have been getting ready for this moment and we will initiate our launch plan to introduce Trogarzo® sequentially on a country-by-country basis as we obtain public reimbursement. Already, we are recording sales in Europe through early access programs, which shows that there is already a high level of interest for our unique HIV treatment,” said Luc Tanguay, President and CEO, Theratechnologies Inc.
“Europe is the second largest pharmaceutical market in the world and the approval of Trogarzo® represents a tremendous opportunity for Theratechnologies. I am also very proud to know that patients in Europe can now look forward to having access to an innovative, safe and effective treatment to help them get to undetectable levels of HIV,” added Luc Tanguay.
About Trogarzo® (Europe)
Trogarzo® is a CD4-directed post-attachment HIV-1 inhibitor. Trogarzo®, in combination with other antiretroviral(s), is indicated for the treatment of adults infected with multidrug resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive antiviral regimen.
Before you receive Trogarzo®, ask your doctor for advice if you are pregnant or plan to become pregnant as it is not known if Trogarzo® may harm your unborn baby. Women who are HIV-positive must not breast feed because HIV infection can be passed on to the baby in breast milk. It is not known if Trogarzo® passes into breast milk.
Talk to your doctor or nurse straight away if you get any of the following serious side effects:
- Signs of a new infection, changes in your immune system, can happen when you start using HIV medicines. Your immune system might get stronger and begin to fight infections that have been hidden in your body for a long time (this is called ‘immune reconstitution inflammatory syndrome’). Look out for new signs of infection after receiving Trogarzo®; these can be different from person to person depending on the type of infection that was hidden and might include fever, headache, difficulty breathing, stomach ache, coughing and swollen glands (lumps and bumps on your body, neck, armpit or groin).
- Allergic reaction (hypersensivity).
The most frequently reported adverse reactions of Trogarzo® include: rash, diarrhea, dizziness, headache, nausea, fatigue and vomiting. These are not all the possible side effects of Trogarzo®.
About Theratechnologies
Theratechnologies (TSX: TH) is a commercial-stage biopharmaceutical 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.
SOURCE: Theratechnologies
Post Views: 33
