Mr. Phillipe Dubuc reports

THERATECHNOLOGIES ANNOUNCES FDA APPROVAL OF TROGARZO(TM) 90-SECOND INTRAVENOUS (IV) PUSH LOADING DOSE

The United States Food and Drug Administration (FDA) has approved Theratechnologies Inc.'s labelling prior approval supplement to include a 2,000-milligram intravenous (IV) push-loading dose for Trogarzo (ibalizumab-uiyk). IV push is a method by which the undiluted medication is pushed by syringe for faster administration into the body's circulation and is designed to make Trogarzo administration easier and more convenient for people with human immunodeficiency virus (HIV) and their health care providers. As a result, more clinics will be able to initiate new patients and provide continuing treatment.

In the U.S., Trogarzo, in combination with other anti-retrovirals (ARVs), is indicated for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant virus failing their current ARV regimen. The label update follows FDA approval of the IV push maintenance dose in October, 2022. With the new label, Trogarzo administration can now take only 90 seconds for the loading dose, as opposed to a 30-minute infusion, and 30 seconds for a maintenance dose every two weeks.

"The approved updated label further simplifies the administration of Trogarzo for heavily treated people with HIV, allowing them to initiate treatment within their own clinics," said Christian Marsolais, PhD, senior vice-president and chief medical officer at Theratechnologies. "This new administration option for the Trogarzo loading dose is the latest innovation in our ongoing efforts to enhance the convenience of non-oral therapy for this important group of people who have limited treatment options and have been taking oral HIV medication for a long time, many for decades," added Dr. Marsolais. Theratechnologies is currently finalizing its application to the FDA for an intramuscular (IM) method of administration of the Trogarzo maintenance dose.

About Trogarzo

Trogarzo (ibalizumab-uiyk) is a long-acting, CD4-directed, postattachment HIV-1 inhibitor. In the United States, Trogarzo, in combination with other anti-retroviral(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 anti-retroviral regimen. Trogarzo is not approved in Canada.

Trogarzo is administered by intravenous 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 millilitres of 0.9 per cent sodium chloride injection, USP. The Trogarzo loading dose can also be administered as an undiluted intravenous (IV) push over 90 seconds, and the maintenance dose can be administered as an undiluted IV push over 30 seconds.

About Theratechnologies Inc.

Theratechnologies is a biopharmaceutical company focused on the development and commercialization of innovative therapies addressing unmet medical needs.

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