TaiMed Biologics has obtained approval from the US Food and Drug Administration (FDA) for HIV drug Trogarzo (ibalizumab-uiyk) for heavily treatment-experienced patients.
The antiretroviral medication is indicated for patients who have not responded to existing drugs due to multidrug resistant HIV (MDR HIV) infection.
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It is administered intravenously once every 14 days by a trained medical professional and used in combination with other antiretroviral medications.
Deputy director of the antiviral products division of the FDA’s Center for Drug Evaluation and Research Jeff Murray said: “While most patients living with HIV can be successfully treated using a combination of two or more antiretroviral drugs, a small percentage of patients who have taken many HIV drugs in the past have multidrug resistant HIV, limiting their treatment options and putting them at a high risk of HIV-related complications and progression to death.
“Trogarzo is the first drug in a new class of antiretroviral medications that can provide significant benefit to patients who have run out of HIV treatment options.”
TaiMed Biologics assessed the safety and efficacy of Trogarzo in a clinical trial involving 40 heavily treatment-experienced MDR HIV-1 patients who had high HIV-RNA levels in their blood even after using antiretroviral drugs.
A week after Trogarzo was added to their antiretroviral regimens, the majority of the subjects demonstrated a significant reduction in virus levels, and 43% experienced HIV-RNA suppression after 24 weeks.
