The FDA has approved a new type of antiretroviral medication for adults living with human immunodeficiency virus (HIV) who have tried multiple medications that are no longer controlling their disease.
Ibalizumab-uiyk (Trogarzo, TaiMed Biologics USA Corp.) is indicated for heavily treatment-experienced patients with multidrug-resistant HIV (MDR HIV). It is administered intravenously once every 14 days by a trained medical professional and used in combination with other antiretroviral medications.
“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,” said Jeff Murray, MD, deputy director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research. “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.”
The safety and efficacy of ibalizumab-uiyk were evaluated in a clinical trial of 40 heavily treatment-experienced patients with MDR HIV-1 who continued to have high levels of virus (HIV-RNA) in their blood despite being on antiretroviral drugs. Many of the participants had previously been treated with 10 or more antiretroviral drugs.
The majority of participants experienced a significant decrease in their HIV-RNA levels one week after ibalizumab-uiyk was added to their failing antiretroviral regimens. After 24 weeks of ibalizumab-uiyk plus other antiretroviral drugs, 43% of the trial’s participants achieved HIV RNA suppression.
The clinical trial focused on the small patient population with limited treatment options and demonstrated the benefit of ibalizumab-uiyk in achieving reduction of HIV RNA. 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.
A total of 292 patients with HIV-1 infection have been exposed to ibalizumab-uiyk IV infusion. The most common adverse reactions to ibalizumab-uiyk were diarrhea, dizziness, nausea, and rash. Severe side effects included rash and changes in the immune system (immune reconstitution syndrome).
The FDA granted this application fast track, priority review, breakthrough therapy, and orphan drug designations.
Source: FDA; March 6, 2018.