Research & Development
Theratechnologies reports US FDA approval for breakthrough multidrug resistant HIV-1 therapy Trogarzo
7 March 2018 -

Pharmaceutical company Theratechnologies Inc (TSX:TH) and its partner TaiMed Biologics Inc on Tuesday jointly announced the receipt of approval from the US Food and Drug Administration (FDA) for Trogarzo (ibalizumab-uiyk) Injection for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.

According to the companies, Trogarzo 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 in combination with other ARTs (antiretroviral treatment ).

The companies said Trogarzo is a humanised monoclonal antibody for the treatment of multidrug resistant HIV-1 infection. Trogarzo binds primarily to the second extracellular domain of the CD4+ T receptor, away from major histocompatibility complex II molecule binding sites. It prevents HIV from infecting CD4+ immune cells while preserving normal immunological function. According to CDC, the HIV virus cannot be transmitted if it is being fully suppressed.

In the companies' clinical studies, Trogarzo in combination with other ARTs reduces viral load and increases CD4+ (T-cell) count among patients with multidrug resistant HIV-1. More than 80% of patients achieved the study's primary endpoint.

Additionally, the patients experienced a clinically-significant mean increase in CD4+ T-cells of 44 cells/mm3 and increases varied based on T-cell count at baseline. Rebuilding the immune system by increasing T-cell count is important as people with multidrug resistant HIV-1 often have the most advanced form of HIV, concluded the company.



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