Trogarzo

Ibalizumab

Ibalizumab has demonstrated both safety and efficacy in the treatment of HIV-1 infection. Its primary use will be in the setting of multidrug resistant virus as part of combination antiretroviral therapy. Further enhancements of ibalizumab to prolong its clearance and broaden its activity are in development.

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Multidrug Resistant HIV Drug Lauded, But Clinical Foundation Not Very Deep.

Trogarzo (ibalizumab-uiyk) is a CD4-directed post-attachment HIV-1 inhibitor, indicated for use with other antiretroviral inhibitors in adults with multidrug resistant HIV-1 infection who aren’t responding to their antiretroviral regimen. It is considered an advance. But FDA approval was based on a study of only 40 people-and it had no control group.

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Ibalizumab: First Global Approval

TaiMed Biologics is developing ibalizumab (Trogarzo™, ibalizumab-uiyk)—a humanised IgG4 monoclonal antibody—as a treatment for HIV-1 infection. Ibalizumab blocks HIV entry into CD4 cells while preserving normal immunological function and is the first CD4-directed post-attachment HIV-1 inhibitor and the first humanised monoclonal antibody for the treatment of HIV/AIDS. This article summarizes the milestones in the development

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FDA approves novel biologic for resistant HIV infection

During a March 6 conference call for investors, Theratechnologies touted ibalizumab-uiyk as the first antiretroviral in its class, the first FDA-approved HIV-1 specific biological product, and the first HIV treatment that does not require daily administration. Officials said that the company was finalizing its pharmacy distribution network and expected the product to be available within

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FDA approves new HIV treatment for patients who have limited treatment options

Today, the U.S. Food and Drug Administration approved Trogarzo (ibalizumab-uiyk), a new type of antiretroviral medication for adult patients living with HIV who have tried multiple HIV medications in the past (heavily treatment-experienced) and whose HIV infections cannot be successfully treated with other currently available therapies (multidrug resistant HIV, or MDR HIV).

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