Officials with the FDA have approved ibalizumab-uiyk (Trogarzo, TaiMed Biologics), the first antiretroviral medication for adults with HIV who cannot be successfully treated with other therapies, according to a press release.

Ibalizumab-uiyk is intended for patients living with HIV who have already tried multiple HIV medications and have limited treatment options.

“While most patients living with HIV can be successfully 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,” Jeff Murray, MD, deputy director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research, said in the press release.

The approval is based on a clinical trial that evaluated the safety and efficacy of ibalizumab-uiyk. The trial included 40 heavily treatment-experienced patients with multi-drug resistant (MDR) HIV-1 who continued to have high levels of virus (HIV-RNA) in their blood despite being on antiretroviral medication. Many of the patients in the trial had previously been treated with 10 more antiretroviral drugs.

After 24 weeks of treatment with ibalizumab-uiyk plus other antiretroviral drugs, 43% of patients achieved HIV RNA suppression.

According to the press release, 292 patients with HIV-1 infection have been treated with ibalizumab-uiyk IV infusion. The most common adverse effects associated with the drug were diarrhea, dizziness, nausea, and rash. Severe adverse effects included rash and changes in the immune system.

The treatment is administered intravenously once every 14 days by a trained medical professional and used in combination with other antiretroviral medications.


FDA approves new HIV treatment for patients who have limited treatment options [news release]. Accessed March 6, 2018.