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United States Department of Health and Human Services Publishes New HIV Treatment Guidelines Including Trogarzo®
MONTREAL, Oct. 29, 2018 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (Theratechnologies) (TSX: TH) is pleased to announce that Trogarzo® (ibalizumab-uiyk) injection is now included in the most recent version of the treatment guidelines issued by the United States Department of Health and Human Services (“DHHS”).
The DHHS guidelines state that “Patients with ongoing detectable viremia who lack sufficient treatment options to construct a fully suppressive regimen may be candidates for the recently approved CD4 post-attachment inhibitor ibalizumab.”
“We are very pleased with these guidelines. They recognize the unique mode of action of Trogarzo® and they confirm its usefulness in patients who cannot decrease their viral load below detection despite being on other antiretrovirals. The DHHS guidelines should give even more traction with physicians and payers in the United States,” said Luc Tanguay, President and CEO, Theratechnologies Inc.
“After the publication of treatment guidelines by the International Antiviral Society and the publication of the phase III clinical trial results in the New England Journal of Medicine, this is yet another major milestone for Trogarzo® which should generate even more interest in the product and support sales,” added Mr. Tanguay.
About Trogarzo® (ibalizumab-uiyk) injection
Trogarzo® is a CD4-directed post-attachment HIV-1 inhibitor.
Trogarzo®, in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen.
Important Safety Information
Before you receive Trogarzo®, tell your healthcare provider if you are pregnant or plan to become pregnant as it is not known if Trogarzo® may harm your unborn baby or if you are breastfeeding or plan to breastfeed as it is not known if Trogarzo® passes into breast milk.
Tell your healthcare provider about all the medicines you take, including all prescription and over-the-counter medicines, vitamins, and herbal supplements.
Changes in your immune system (Immune Reconstitution Inflammatory Syndrome) can happen when you start taking HIV-1 medicines. Your immune system might get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your health care provider right away if you start having new symptoms after starting your HIV-1 medicine.
The most common side effects of Trogarzo® include: diarrhea, dizziness, nausea and rash.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Trogarzo®. For more information, ask your healthcare provider or pharmacist.
Full prescribing information available at www.trogarzo.com.
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.
This press release contains forward-looking statements and forward-looking information, or, collectively, forward-looking statements, within the meaning of applicable securities laws, that are based on our management’s belief and assumptions and on information currently available to our management. You can identify forward-looking statements by terms such as “may”, “will”, “should”, “could”, “would”, “outlook”, “believe”, “plan”, “envisage”, “anticipate”, “expect” and “estimate” or the negatives of these terms, or variations of them. The forward-looking statements contained in this press release include, but are not limited to, the usefulness of Trogarzo®, the traction generated by Trogarzo® with physicians and payers and sales support.
Forward-looking statements are based upon a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond Theratechnologies’ control that could cause actual results to differ materially from those that are disclosed in or implied by such forward-looking information. These assumptions include but are not limited to, the following: payers and treating physicians will adopt the DHHS guidelines as it relates to Trogarzo® and sales of Trogarzo® will grow over time.
These risks and uncertainties include, but are not limited to, the risk that the treating physicians will not adopt the DHHS guidelines as it relates to Trogarzo® and that sales of Trogarzo® do not grow over time.
We refer potential investors to the “Risk Factors” section of our Annual Information Form dated February 6, 2018 available on SEDAR at www.sedar.com for additional risks and uncertainties about Theratechnologies and its business. The reader is cautioned to consider these and other risks and uncertainties carefully and not to put undue reliance on forward-looking statements. Forward-looking statements reflect current expectations regarding future events and speak only as of the date of this press release and represent our expectations as of that date. We undertake no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise, except as may be required by applicable law.
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