Theratechnologies (THTX) Trogarzo Approved by FDA for 30-Second Intravenous (IV) Push, Simplifying HIV Treatment for Heavily Treatment-Experienced Population

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 United States Food and Drug Administration (FDA) approved Trogarzo^® (ibalizumab-uiyk) for administration by intravenous (IV) push, a method by which the undiluted medication is “pushed” by syringe for faster administration into the body’s circulation. In the U.S., Trogarzo^®, 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 Trogarzo^®, 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 today’s approval, the maintenance dose can be administered as an undiluted IV push over 30 seconds.

“Today marks an important milestone in our journey to improve the lives of people living with HIV who have been heavily treated,” said Dr. Christian Marsolais, Chief Medical Officer, Theratechnologies. “The evolution of Trogarzo^® 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.”

“We 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,” said Nelson Vergel, founder of the Program for Wellness Restoration (PoWeR). “The 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.”

The approval of the Trogarzo^® 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 Trogarzo^® once every two weeks administered via IV push. Results show that the safety and PK profile of Trogarzo^® 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 Trogarzo^® in treatment-experienced patients with multidrug-resistant HIV-1. In the TMB-301 trial, patients receiving Trogarzo^®, 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 Trogarzo^® in the clinical development program, including 19 subjects who received Trogarzo^® via IV push. Trogarzo^® 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.

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