The Food and Drug Administration (FDA) has approved Trogarzo® (ibalizumab-uiyk) for administration by intravenous (IV) push for maintenance dosing.
Trogarzo is a CD4-directed post-attachment human immunodeficiency virus type 1 (HIV-1) inhibitor. It is indicated in combination with other antiretroviral(s) for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen.
In March 2018, Trogarzo received FDA approval to be administered intravenously as a single loading dose followed by a 15-minute maintenance dose every 2 weeks. With today’s approval, the Trogarzo maintenance dose can be administered as an undiluted IV push over 30 seconds.
The approval was based on data from the phase 3 TMB-302 trial (ClinicalTrials.gov Identifier: NCT03913195), which evaluated the safety and pharmacokinetic profile of Trogarzo 800mg administered via IV push once every 2 weeks. Results showed that the safety and pharmacokinetics of Trogarzo administered as IV push were similar to that of IV infusion in treatment-experienced patients with MDR HIV-1.
“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,” said Dr Christian Marsolais, Chief Medical Officer, Theratechnologies. “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.”
This article originally appeared on MPR
Theratechnologies’ Trogarzo® approved by FDA for 30-second intravenous (IV) push, simplifying HIV treatment for heavily treatment-experienced population. News release. Theratechnologies Inc. Accessed October 3, 2022. https://www.globenewswire.com/news-release/2022/10/03/2527271/0/en/Theratechnologies-Trogarzo-Approved-by-FDA-for-30-Second-Intravenous-IV-Push-Simplifying-HIV-Treatment-for-Heavily-Treatment-Experienced-Population.html