WEDNESDAY, March 7, 2018 -- Trogarzo, or ibalizumab-uiyk, has been approved by the U.S. Food and Drug Administration to treat AIDS-causing HIV that has 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.
"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," said Dr. Jeff Murray, deputy director of the agency's Division of Antiviral Products.
"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," Murray added.
Trogarzo was evaluated in clinical studies involving 40 people 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 immune system abnormalities.
Trogarzo is produced by TaiMed Biologics, based in Taiwan.More information
Visit the FDA to learn more about Trogarzo.
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