Theratechnologies Submits sBLA for Trogarzo® Intramuscular (IM) Method of Administration to FDA

Rhea-AI Summary

Theratechnologies Inc. (TSX: TH) (NASDAQ: THTX) files supplemental Biologics License Application for intramuscular method of administration for Trogarzo® (ibalizumab-uiyk) maintenance dose for treatment of heavily treatment-experienced adults with HIV, following recent FDA approval of IV push loading dose.

Insights

Medical Research Analyst

The submission of a supplemental Biologics License Application (sBLA) for an intramuscular (IM) method of administration for Trogarzo® represents a potential advancement in the treatment paradigm for heavily treatment-experienced adults with multidrug-resistant HIV-1 infection. This development could have significant implications for patient adherence and quality of life, as it offers a less invasive and potentially more convenient alternative to the existing intravenous (IV) administration.

From a medical research perspective, the approval of an IM maintenance dosing regimen could enhance therapeutic outcomes by improving compliance among patients, a critical factor in managing chronic conditions like HIV. Moreover, the shift from specialized infusion clinics to potentially receiving treatment in various healthcare settings or even at home could reduce overall healthcare costs and improve patient access to treatment.

It's essential to monitor the FDA's response to the sBLA submission, as the regulatory decision will directly impact the company's market potential and patient access to this new administration method. The acknowledgment letter and the Prescription Drug User Fee Act (PDUFA) goal date will be key indicators of the expected timeline for potential market entry.

Healthcare Economist

The introduction of an IM administration method for Trogarzo® could lead to a shift in healthcare resource allocation, particularly if it reduces the need for specialized infusion clinics. This could result in a redistribution of healthcare spending towards more cost-effective treatment delivery methods. Additionally, the convenience of IM dosing may lead to higher patient satisfaction, which is increasingly considered a critical outcome in value-based healthcare models.

From an economic standpoint, the potential market expansion due to improved patient adherence and the broadening of administration settings could increase the revenue stream for Theratechnologies. However, it's also vital to consider the pricing strategy for the IM formulation, as it could affect payer coverage decisions and the overall adoption rate in the competitive HIV treatment market.

Long-term economic implications hinge on the clinical outcomes associated with the IM administration. If the new method demonstrates comparable or superior efficacy and safety to IV administration, it could lead to a paradigm shift in treatment preferences and establish a new standard of care for heavily treatment-experienced HIV patients.

Pharmaceutical Market Analyst

The sBLA submission for Trogarzo®'s IM maintenance dosing is a strategic move by Theratechnologies to differentiate its product in the HIV treatment market. The ability to offer a non-oral, less invasive treatment option addresses a clear unmet need within a specific patient population. This could potentially enhance the competitive positioning of Trogarzo® against other antiretrovirals (ARVs).

Analyzing the market dynamics, the approval of the IM method could lead to increased market share for Theratechnologies, as it would cater to patient preferences for convenience and ease of use. Furthermore, the recent FDA approval of a 2,000-mg IV push loading dose for Trogarzo®, which simplifies the initiation of treatment, complements the IM submission by providing a more comprehensive and patient-friendly regimen.

It is crucial to monitor the adoption rates post-approval and assess how the IM dosing option impacts prescribing behaviors. Stakeholders should also consider potential competitive responses, such as pricing adjustments or the introduction of similar administration methods by competitors, which could influence Trogarzo®'s market performance.

• Trogarzo^® IM maintenance dosing aims to further enhance the convenience of non-oral therapy for heavily treatment-experienced adults with HIV
• Submission comes on the heels of the recent FDA approval of the Trogarzo^® IV push loading dose  

This news release constitutes a “designated news release” for the purposes of the Company’s prospectus supplement dated December 16, 2021 to its short form base shelf prospectus dated December 14, 2021.

MONTREAL, Jan. 02, 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today announced that the Company has filed a supplemental Biologics License Application (sBLA) for an intramuscular (IM) method of administration for the maintenance dose of Trogarzo^® (ibalizumab-uiyk) to the United States Food and Drug Administration (FDA) for review. In the U.S., Trogarzo^®, in combination with other antiretrovirals (ARVs), is indicated for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current ARV regimen.

The Trogarzo^® IM sBLA submission follows the recent FDA approval of the Company’s Labelling Prior Approval Supplement to include a 2,000-mg intravenous (IV) push loading dose, which can now be delivered in as little as 90 seconds and no longer requires treatment to be initiated in specialized infusion clinics. The potential addition of an entirely new method of administration for the maintenance dose via a rapid IM injection every two weeks could further simplify the Trogarzo^® treatment regimen.

“The intramuscular method of administration, if approved for the maintenance dose, will give patients and their health care providers more options for Trogarzo^® treatment and without the need for regular IV placement,” said Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer at Theratechnologies. “Our vision through the introduction of IV push administration and, hopefully soon, IM administration, is that Trogarzo^® treatment will be a less invasive and more convenient proposition for heavily treatment-experienced adults with HIV, a population that has long had limited non-oral treatment options.”

In accordance with the FDA’s filing review period, Theratechnologies expects to receive an acknowledgment letter of the sBLA application within 30 days along with a Prescription Drug User Fee Act (PDUFA) goal date.

About Trogarzo^®

Trogarzo^® (ibalizumab-uiyk) is a long-acting, CD4-directed, post-attachment HIV-1 inhibitor. In the United States, 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. Trogarzo^® is not approved in Canada.

Trogarzo^® is administered by intravenous (IV) infusion 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 Trogarzo^® loading dose can also be administered as an undiluted IV push over 90 seconds, and the maintenance dose can be administered as an undiluted IV push over 30 seconds.

Important Safety Information

Do not receive Trogarzo^® if you have had an allergic reaction to Trogarzo^® or any of the ingredients in Trogarzo^®. Trogarzo^® can cause allergic reactions, including serious reactions, during and after infusion. Tell your healthcare provider or nurse, or get medical help right away if you experience any symptoms of an allergic reaction. Before you receive Trogarzo^®, tell your healthcare provider about all of your medical conditions, including 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 healthcare 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 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.sedarplus.ca and on EDGAR at www.sec.gov. Follow Theratechnologies on Linkedin and Twitter.

Forward-Looking Information

This press release contains forward-looking statements and forward-looking information (collectively, the “Forward-Looking Statements”) within the meaning of applicable securities laws, that are based on management’s beliefs and assumptions and on information currently available to it. You can identify forward-looking statements by terms such as “may”, “will”, “should”, “could”, “promising”, “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, statements regarding the approval of the IM method of administration for the maintenance dose of Trogarzo^® by the FDA and the expansion of treatment options for heavily treatment-experienced adults with HIV. 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 contained in this press release. These assumptions include, without limitation, the approval by the FDA of the IM method of administration for the maintenance dose of Trogarzo^®, if and when approved, and the market acceptance of the IM method of administration for the maintenance dose of Trogarzo^®. Forward-Looking Statements assumptions are subject to a number of risks and uncertainties, many of which are beyond the Company’s 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, the non-approval by the FDA of the IM method of administration for the maintenance dose of Trogarzo^®, even if approved, lack of market acceptance of the IM method of administration for the maintenance dose of Trogarzo^® by patients and physicians, the difficulty in switching patients from the current method of administration of the loading dose to a new one, and the incapacity to grow sales of Trogarzo^® despite the introduction of this new method of administration. We refer current and potential investors to the “Risk Factors” section of our Annual Information Form dated February 27, 2023, available on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov as an exhibit to our report on Form 40-F dated February 28, 2023, under Theratechnologies’ public filings. 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:
Philippe Dubuc
Senior Vice President and Chief Financial Officer
pdubuc@theratech.com
438-315-6608

FAQ

What is the purpose of Theratechnologies Inc.'s (TSX: TH) (NASDAQ: THTX) supplemental Biologics License Application (sBLA) filing?

The purpose of the sBLA filing is to seek approval for an intramuscular method of administration for the maintenance dose of Trogarzo® (ibalizumab-uiyk) for the treatment of heavily treatment-experienced adults with HIV.

What is the indication for Trogarzo® in the U.S.?

In the U.S., Trogarzo® is indicated for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen.

What recent FDA approval has Theratechnologies Inc. received?

Theratechnologies Inc. recently received FDA approval for the Labelling Prior Approval Supplement to include a 2,000-mg intravenous (IV) push loading dose for Trogarzo®.

What is the potential impact of the intramuscular method of administration for the maintenance dose of Trogarzo®?

The potential addition of an intramuscular method of administration for the maintenance dose could further simplify the Trogarzo® treatment regimen and provide more options for patients and their healthcare providers, without the need for regular IV placement.

What is the expected timeline for the FDA's review of the sBLA application?

Theratechnologies Inc. expects to receive an acknowledgment letter of the sBLA application within 30 days, along with a Prescription Drug User Fee Act (PDUFA) goal date, in accordance with the FDA's filing review period.