Trogarzo (ibalizumab-uiyk), was approved by the a U.S. Food and Drug Administration on March 06, 2018. This new antiretroviral medication is made by TaiMed Biologics USA, and is for adult patients living with HIV, who have tried multiple HIV medications in the past (heavily treatment-experienced), and whose HIV infections cannot be successfully treated with other currently available therapies (multidrug resistant HIV, or MDR HIV). Deputy director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research, Dr. Jeff Murray, stated that “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.”
Trograzo was evaluated in a clinical trial of 40 heavily treatment-experienced patients with MDR HIV-1, who despite being on antiretroviral medications, continued to have high levels of virus (HIV-RNA) in their blood. Many of these 40 patients had been previously treated with 10 or more antiretroviral drugs. According to the FDA’s press release, “the majority of participants experienced a significant decrease in their HIV-RNA levels one week after Trogarzo was added to their failing antiretroviral regimens. After 24 weeks of Trogarzo plus other antiretroviral drugs, 43 percent of the trial’s participants achieved HIV RNA suppression.” The most common adverse reactions to Trogarzo were diarrhea, dizziness, nausea and rash. Severe side effects included rash and changes in the immune system (immune reconstitution syndrome).
Reference: U.S. Food & Drug Administration. (2018, March 06). FDA approves new HIV treatment for patients who have limited treatment options. Retrieved March 07, 2018, from FDA News Release: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm599657.htm