FDA Approves New Medication for Drug-Resistant HIV
TUESDAY, March 6, 2018 -- Trogarzo (ibalizumab-uiyk) has been approved by the U.S. 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.
© 2020 HealthDay. All rights reserved.
Posted: March 2018
More News Resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
- Monthly Update Archive
Subscribe to our Newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.