The FDA has approved
ibalizumab-uiyk (Trogarzo), a new HIV treatment for patients who have limited treatment options.
TaiMed Biologics’ antiretroviral medication gained approved for adult patients living with HIV who have been treated with multiple HIV medications in the past and whose HIV infection did not respond to currently available antiretroviral therapies.
“While most patients living with HIV can successfully be treated using a combination of 2 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,” said Jeff Murray, MD, deputy director, Division of Antiviral Products, FDA Center for Drug Evaluation and Research, in a statement. “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.”
Ibalizumab-uiyk is administered intravenously once every 14 days and used in combination with other antiretroviral medications. The drug’s safety and efficacy were assessed in a clinical trial of 40 heavily treatment-experienced patients with MDR HIV-1 whose high levels of virus in their blood persisted despite being on antiretroviral medications. Some patients had been previously treated with 10 or more antiretroviral drugs.
A significant decrease in HIV-RNA levels were observed in the majority of patients a week after ibalizumab-uiyk was added to their treatment regimens. At 24 weeks, 43% of the patients achieved HIV RNA suppression. According to the FDA, the seriousness of the disease, the need to individualize other drugs in the treatment regimen, and safety data from other trials were considered in evaluating the ibalizumab-uiyk development program.
The FDA granted the application Fast Track, Priority Review, Breakthrough Therapy, and Orphan Drug designations.