- Decrease maintenance dose from 15 minute IV infusion to 30 second undiluted IV push every 2 weeks
- Safety Profile of Trogarzo®IV push similar to IV infusion
- A new dosing regimen designed to facilitate maintenance dosing for patients and providers and enable more clinics to carry out the treatment
MONTREAL, Oct. 3, 2022 (GLOBE NEWSWIRE) — Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX) is focused on developing and commercializing innovative therapeutics. A biopharmaceutical company that The U.S. Food and Drug Administration (FDA) has announced that it has approved Trogarzo.® (ibalizumab-uiyk) for administration by intravenous (IV) push. A method of rapidly administering an undiluted drug into the systemic circulation by “pushing” it with a syringe.In America, Trogarzo®in combination with other antiretroviral drugs (ARVs) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in treatment-experienced adults with multidrug-resistant virus who have failed current ARV regimens. Adapted.
FDA Approves Trogarzo First®, a novel long-acting monoclonal antibody, given as a single intravenous loading dose in March 2018, followed by 15-minute maintenance doses every 2 weeks. Following today’s approval, the maintenance dose can be administered as an undiluted IV push over 30 seconds.
Dr. Christian Marsolet, Chief Medical Officer, Theratechnologies, said: “Evolution of Trogarzo® Dosing from an intravenous infusion to an intravenous push means less clinic preparation and treatment time for patients and their healthcare providers, perhaps allowing more clinics to perform this treatment. will be We are proud of our long-term commitment to bringing much-needed parenteral innovations to change the treatment paradigm for treatment-experienced people living with HIV. “
“We are grateful for continued innovation to help people living with HIV. We are grateful that this group, which is rarely the focus of treatment advances, now has proven and more convenient treatment options.” Wellness Restoration Program (PoWeR): “The availability of more easily administered treatments is critically important for all HIV patients, and this advance will help reduce the virus and It can make it easier to maintain undetectability.”
Approval of Trogarzo® The IV push dosing regimen is based on the TMB-302 study, a Phase 3 study evaluating the safety and pharmacokinetic (PK) profile of the 800 mg dose of Trogarzo.® Administered by IV push every 2 weeks.The results showed that the safety and PK profile of Trogarzo was® Administration by IV push is similar to administration by IV infusion. These findings were observed in the Phase 3 TMB-301 trial evaluating the safety and efficacy of Trogarzo.® Treatment-experienced patients with multidrug-resistant HIV-1. In the TMB-301 trial, patients who received trogarzo®, in combination with other ARVs, experienced a significant reduction in viral load and a clinically significant increase in CD4+ (T-cell) numbers.A total of 350 subjects received Trogarzo® In a clinical development program involving 19 subjects receiving Trogarzo® Via IV push.Trogarzo® In continuation of TMB-302 research, intramuscular administration is also being studied. The study is now fully enrolled and the final patient visit is scheduled for November 2022.
Trogarzo® It is a long-acting CD4-directed post-adhesion HIV-1 inhibitor.In America, Trogarzo® (ibalizumab-uiyk) in combination with other antiretroviral agents for human immunodeficiency virus type 1 (HIV-1) in heavily treatment-experienced adults with failed multidrug-resistant (MDR) HIV-1 infection Indicated for the treatment of infections. their current antiretroviral regimen.In the European Union, Trogarzo® MDR It is approved for the treatment of adults infected with HIV-1.
Trogarzo® It is administered intravenously (IV) as a single loading dose of 2,000 mg, followed by a maintenance dose of 800 mg every 2 weeks after dilution in 250 mL of 0.9% Sodium Chloride Injection (USP).Trogarzo® The maintenance dose may also be administered as an intravenous push of the undiluted solution over 30 seconds.
Important safety information
I don’t receive Trogarzo® If you have ever had an allergic reaction to Trogarzo ® or any of the ingredients of Trogarzo®Trogarzo® May cause allergic reactions, including severe reactions, during and after injection. If you have symptoms of an allergic reaction, tell your healthcare provider or nurse, or see a doctor right away.Before Receiving Trogarzo®Tell your healthcare provider about all medical conditions, including if you are pregnant or plan to become pregnant.® Trogarzo if it may harm your unborn baby or if you are breastfeeding or planning to breastfeed® 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.
When you start taking HIV-1 drugs, changes in your immune system (immune-reconstituting inflammatory syndrome) can occur. Your immune system is strengthened and can begin to fight infections that have been hiding in your body for a long time. Tell your healthcare provider right away if you start having new symptoms after you start taking HIV-1 medicines.Most Common Side Effects of Trogarzo® Inclusions: diarrhea, dizziness, nausea, rash. Tell your healthcare provider if you have any side effects that bother you or do not go away.These are not all possible side effects of Trogarzo®Ask your healthcare provider or pharmacist for more information.
Full prescribing information is available at www.trogarzo.com.
About Cera Technologies
Theratechnologies (TSX: TH) (NASDAQ: THTX) is a biopharmaceutical company focused on developing and commercializing innovative therapies to address unmet medical needs. More information about Theratechnologies is available on his company website at www.theratech.com, SEDAR at www.sedar.com, and EDGAR at www.sec.gov.
This press release contains forward-looking statements and forward-looking statements within the meaning of applicable securities laws that are based on the beliefs and assumptions of our management and information currently available to our management. It contains information (collectively, “forward-looking statements”) about Forward-looking statements “may,” “will,” “should,” “may,” “will,” “expect,” “believe,” and “plan.” can be identified by terms such as , “assume”, and “anticipate”. , “expect” and “estimate”, or the negative forms of these terms, or variations thereof. Forward-looking statements contained in this press release include, but are not limited to, statements regarding simplification and improvement of treatment for people living with HIV and an increase in the number of clinics where Trogarzo can be administered.®the final patient visit, scheduled for November 2022, relates to an open-label intramuscular phase 3 trial and expected results from such a phase 3 trial administering trogarzo.® intramuscularly. Although the forward-looking statements contained in this press release are based on what we believe to be reasonable assumptions in light of currently available information, actual results may differ from the forward-looking statements. investors are cautioned not to place undue reliance on these statements. Certain assumptions made in making forward-looking statements include:IV Push Administration of Trogarzo Maintenance Dose® It will prove simpler and more convenient, allowing more clinics to administer Trogarzo®the timeline for the last patient visit described therein has been met and the results are derived from an open-label intramuscular phase 3 study with Trogarzo® At least as good or better than observed with the IV push method of administration, and if submitted to the FDA, intramuscular administration of trogarzo® Approved by FDA. The assumptions made in forward-looking statements are subject to a number of risks and uncertainties. Many of them are beyond the control of Cera Technologies and actual results could differ materially from those disclosed or implied in such forward-looking statements. These risks and uncertainties include, but are not limited to, those related to or arising from the lack of market acceptance of Trogarzo’s IV push mode of administration.®number of clinics administering Trogarzo® No change, delays related to last patient visit, failure of phase 3 trial demonstrating safe and effective use of intramuscular mode of administration of Trogarzo® Non-approval of such intramuscular modes of administration by the FDA. To current and potential investors, please refer to the “Risk Factors” section of our Annual Information Form dated February 23, 2022 – F indicates additional risks associated with the Company, dated February 24, 2022 Based on Theratechnologies official papers on Readers are cautioned to carefully consider these and other risks and uncertainties and not to place undue reliance on forward-looking statements. Forward-looking statements reflect our current expectations of future events, speak only as of the date of this press release, and represent our expectations as of such 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, circumstances or otherwise, except as required by applicable law.
Senior Director, Communications & Corporate Affairs
Inquiries from investors:
Senior Director of Investor Relations
Theratechnologies’ Trogarzo® With 30-Second Intravenous (IV) Push Approved by FDA to Simplify HIV Treatment in Treatment-Experienced Population, Canadian Business Journal
Source link Theratechnologies’ Trogarzo® With 30-Second Intravenous (IV) Push Approved by FDA to Simplify HIV Treatment in Treatment-Experienced Population, Canadian Business Journal