- Reduces maintenance dose from a 15-minute IV infusion to a 30-second, undiluted IV push every two weeks
- Safety profile of Trogarzoยฎ IV push similar to that of IV infusion
- New method of administration designed to make maintenance dosing easier for patients and health care providers and allow more clinics to administer treatment
MONTREAL, Oct. 03, 2022 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (โTheratechnologiesโ or the โCompanyโ) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today announced that the United States Food and Drug Administration (FDA) approved Trogarzoยฎ (ibalizumab-uiyk) for administration by intravenous (IV) push, a method by which the undiluted medication is โpushedโ by syringe for faster administration into the bodyโs circulation. In the U.S., Trogarzoยฎ, in combination with other antiretrovirals (ARVs), is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug-resistant virus failing their current ARV regimen.
The FDA originally approved Trogarzoยฎ, a novel, long-acting monoclonal antibody, in March 2018 to be administered intravenously as a single loading dose followed by a 15-minute maintenance dose every two weeks. Following todayโs approval, the maintenance dose can be administered as an undiluted IV push over 30 seconds.
โToday marks an important milestone in our journey to improve the lives of people living with HIV who have been heavily treated,โ said Dr. Christian Marsolais, Chief Medical Officer, Theratechnologies. โThe evolution of Trogarzoยฎ administration from intravenous infusion to intravenous push means less preparation and treatment time in clinics for patients and their health care providers, possibly allowing for more clinics to administer this treatment. We are proud of our long-term commitment to bring much needed non-oral innovations to help shift the treatment paradigm for heavily treatment-experienced people living with HIV.โ
โWe are grateful for continued innovation to help people living with HIV, and it is comforting to know that this group, which is rarely the focus of treatment advancements, now has a proven, more convenient treatment option,โ said Nelson Vergel, founder of the Program for Wellness Restoration (PoWeR).ย โThe availability of treatments that are easier to administer is of real importance to all people with HIV, and this advancement could make it easier to suppress the virus and maintain undetectability.โ
The approval of the Trogarzoยฎ IV push method of administration is based on study TMB-302, a Phase 3 trial that evaluated the safety and pharmacokinetic (PK) profile of an 800-mg dose of Trogarzoยฎ once every two weeks administered via IV push. Results show that the safety and PK profile of Trogarzoยฎ administered via IV push are similar to that of IV infusion administration. These findings were observed in the Phase 3 TMB-301 trial, which evaluated the safety and efficacy of Trogarzoยฎ in treatment-experienced patients with multidrug-resistant HIV-1. In the TMB-301 trial, patients receiving Trogarzoยฎ, in combination with other ARVs, experienced significant reductions in viral load and a clinically significant increase in CD4+ (T-cell) count. A total of 350 subjects have received Trogarzoยฎ in the clinical development program, including 19 subjects who received Trogarzoยฎ via IV push. Trogarzoยฎ is also being studied for intramuscular injection administration in the continuation of the TMB-302 study. The study is now fully enrolled, with the last patient visit scheduled for November 2022.
About Trogarzoยฎ
Trogarzoยฎ is a long-acting, CD4-directed, post-attachment HIV-1 inhibitor. In the United States, Trogarzoยฎ (ibalizumab-uiyk), 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 (MDR) HIV-1 infection failing their current antiretroviral regimen. In the European Union, Trogarzoยฎ is approved for the treatment of adults infected with MDR HIV-1 for whom it is otherwise not possible to construct a suppressive antiviral regimen.
Trogarzoยฎ is administered intravenously (IV) as a single loading dose of 2,000 mg followed by a maintenance dose of 800 mg every two weeks after dilution in 250 mL of 0.9% Sodium Chloride Injection, USP. The Trogarzoยฎ maintenance dose can also be administered as an undiluted intravenous push over 30 seconds.
Important Safety Information
Do not receive Trogarzoยฎ if you have had an allergic reaction to Trogarzo ยฎ or any of the ingredients in Trogarzoยฎ. Trogarzoยฎ can cause allergic reactions, including serious reactions, during and after infusion. Tell your health care provider or nurse, or get medical help right away if you get any symptoms of an allergic reaction. Before you receive Trogarzoยฎ, tell your health care provider about all of your medical conditions, including if you are pregnant or plan to become pregnant, as it is not known if Trogarzoยฎ may harm your unborn baby, or if you are breastfeeding or plan to breastfeed, as it is not known if Trogarzoยฎ passes into breast milk. Tell your health care 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 Trogarzoยฎ include: diarrhea, dizziness, nausea and rash. Tell your health care 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 Trogarzoยฎ. For more information, ask your health care provider or pharmacist.
Full prescribing information is available at www.trogarzo.com.
About Theratechnologies
Theratechnologies (TSX: TH) (NASDAQ: THTX) is a biopharmaceutical company focused on the development and commercialization of innovative therapies addressing unmet medical needs. Further information about Theratechnologies is available on the Company's website at www.theratech.com, on SEDAR at www.sedar.com, and on EDGAR at www.sec.gov.
Forward-Looking Information
This press release contains forward-looking statements and forward-looking information (collectively, โForward-Looking Statementsโ), within the meaning of applicable securities laws, that are based on our managementโs beliefs and assumptions and on information currently available to our management. You can identify Forward-Looking Statements by terms such as "may", "will", "should", "could", โwouldโ, "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, statements regarding the simplification and improvement of treatment for people living with HIV, the increase in the number of clinics that could administer Trogarzoยฎ, the last patient visit scheduled for November 2022 related to the open-label intramuscular Phase 3 study and the expected results from such Phase 3 study administering Trogarzoยฎ intramuscularly. Although the Forward-Looking Statements contained in this press release are based upon what the Company believes are reasonable assumptions in light of the information currently available, investors are cautioned against placing undue reliance on these statements since actual results may vary from the Forward-Looking Statements. Certain assumptions made in preparing the Forward-Looking Statements include that: the IV-push method of administration of the maintenance dose of Trogarzoยฎ will be found to be simpler and more convenient and will allow more clinics to administer Trogarzoยฎ, the timeline described therein for the last patient visit will be met, the results to be derived from the open-label intramuscular Phase 3 study using Trogarzoยฎ will be at least equal or superior to those observed with the IV-push method of administration and, if and when filed to the FDA, the intramuscular administration of Trogarzoยฎ will be approved by the FDA. Forward-Looking Statements assumptions are subject to a number of risks and uncertainties, many of which are beyond Theratechnologiesโ control that could cause actual results to differ materially from those that are disclosed in or implied by such Forward-Looking Statements. These risks and uncertainties include, but are not limited to, those related to or arising from the non-acceptance by the marketplace of the IV-push mode of administration of Trogarzoยฎ, the number of clinics administering Trogarzoยฎ remains unchanged, a delay occurs in connection with the visit of the last patient, the failure of the Phase 3 study to demonstrate the safe and effective use of the intramuscular mode of administration of Trogarzoยฎ and the non-approval by the FDA of such intramuscular mode of administration. We refer current and potential investors to the โRisk Factorsโ section of our Annual Information Form dated February 23, 2022 available on SEDAR at www.sedar.com and on EDGAR at www.sec.gov as an exhibit to our report on Form 40-F dated February 24, 2022 under Theratechnologiesโ public filings for additional risks related to the Company. 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.
Contacts:
Media inquiries:
Julie Schneiderman
Senior Director, Communications & Corporate Affairs
communications@theratech.com
1-514-336-7800
Investor inquiries:
Elif McDonald
Senior Director, Investor Relations
ir@theratech.com
1-438-315-8563
