(HealthDay News) — Trogarzo (ibalizumab-uiyk) has been approved by the US Food and Drug Administration to treat adult patients living with HIV who have not responded to other antiretroviral medications.
Trogarzo is given intravenously once every 14 days in combination with other antiretroviral drugs, the FDA said Tuesday in a news release. The drug was evaluated in clinical studies involving 40 patients who continued to have high blood levels of HIV despite use of antiretroviral drugs. After 24 weeks of Trogarzo and other drugs, 43 percent of trial participants achieved HIV suppression, the FDA said.
The most common adverse reactions to Trogarzo were diarrhea, dizziness, nausea, and rash. More severe side effects included rash and immune reconstitution syndrome.
“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,” Jeff Murray, M.D., deputy director of the FDA’s Division of Antiviral Products, said 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.”
Trogarzo is produced by TaiMed Biologics, based in Taiwan.
- FDA approves new HIV treatment for patients who have limited treatment options [press-release]. US Food & Drug Administration. March 6, 2018. Accessible at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm599657.htm