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FDA Approves Novel Biologic for Multidrug-Resistant HIV-1

March 8, 2018

The Food and Drug Administration (FDA) has approved Trogarzo (ibalizumab-uiyk, Theratechnologies Inc.) for the treatment of heavily treatment-experienced adults with multidrug-resistant human immunodeficiency virus type 1 (MDR HIV-1) infection that is not responding to a current antiretroviral regimen. Trogarzo is indicated for use only in combination with other antiretroviral medications.

Trogarzo is a first-in-class viral entry inhibitor that targets a human protein rather than attacking HIV directly. It binds to extracellular domain 2 of CD4 receptors, thereby blocking entry of HIV into CD4 lymphocytes. According to the product label, Trogarzo is administered via intravenous (IV) infusion every 2 weeks.

FDA approval for Trogarzo is based on results of the single-arm TMB-301 study, which evaluated the therapy in 40 heavily treatment-experienced adults with MDR HIV-1, many of whom had previously been treated with 10 or more antiretroviral drugs. TMB-301 study results are unpublished to date.

Trogarzo is expected to be commercially available in 6 weeks.


Food and Drug Administration (FDA). FDA approves new HIV treatment for patients who have limited treatment options [news release]. March 6, 2017. Available at: click here. Accessed March 7, 2018.