FDA approves Trogarzo 90-second intravenous (IV) push loading dose for the treatment of HIV infection – Theratechnologies Inc

Theratechnologies Inc. announced that the FDA has approved the company’s Labelling Prior Approval Supplement to include a 2000-mg 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 HIV and their health care providers. As a result, more clinics will be able to initiate new patients and provide ongoing treatment. 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 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, Ph.D., 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, 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 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 intravenous (IV) push over 90 seconds, and the maintenance dose can be administered as an undiluted IV push over 30 seconds.