The US Food and Drug Administration (FDA) has approved ibalizumab-uiyk (Trogarzo, Theratechnologies Inc) for the treatment of adults with multidrug-resistant HIV-1 (MDR HIV-1).
Ibalizumab is a humanized monoclonal antibody administered intravenously every 14 days by a trained medical professional. It is used in combination with other antiretroviral drugs.
“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,” Jeff Murray, MD, deputy director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research, said in a news release. “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. New treatment options may be able to improve their outcomes.”
The FDA granted priority review status to ibalizumab on June 30, 2017, according to a company news release.
Ibalizumab is “the first antiretroviral treatment (ART) with a new mechanism of action to be introduced in nearly 10 years and the only treatment that does not require daily dosing,” the company said in the release.
The FDA previously granted the application Breakthrough Therapy, Orphan Drug, and Fast Track designations, the company said in a November 1, 2016, news release.
The approval follows consideration of data from a clinical trial that included 40 heavily treatment-experienced patients with MDR HIV-1 who still had high levels of HIV-RNA in their blood after treatment with other antiretroviral medications. Many study participants had been treated with at least 10 antiretroviral drugs in the past. In most participants, HIV-RNA levels fell significantly 1 week after the addition of ibalizumab to the failing antiretroviral regimens. After 24 weeks of receiving ibalizumab with their other antiretroviral drugs, 43% of participants experienced HIV-RNA suppression.
When evaluating the drug’s development program, the FDA considered the seriousness of patients’ illness, the need to individualize other medications in patients’ treatment regimens, and safety data obtained in other clinical trials.
To date, 292 patients with HIV-1 infection have received ibalizumab intravenous infusion. The most frequently seen adverse effects were diarrhea, dizziness, nausea, and rash. Severe adverse effects included rash and immune reconstitution syndrome.
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