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.
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.