Theratechnologies announces FDA approval of Trogarzo IV push loading dose

Theratechnologies announced that the United States Food and Drug Administration, FDA, has approved the company’s Labelling Prior Approval Supplement to include a 2000-mg intravenous push loading dose for Trogarzo. In the U.S., Trogarzo, in combination with other antiretrovirals, 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(R) 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(R) 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.