The U.S. Food and Drug Administration (FDA) has approved ibalizumab-uiyk (Trogarzo), developed by TaiMed Biologics and intended for adults with HIV.
The approved indication for the antiretroviral medication is adult patients who have tried multiple HIV medications in the past and whose infections cannot be successfully treated with other currently available therapies, including those with multidrug-resistant (MDR) HIV. Ibalizumab-uiyk is to be administered intravenously once every 14 days by a trained medical professional and used in combination with other antiretroviral medications.
The approval was based on data collected in a clinical trial that evaluated the safety and efficacy of ibalizumab-uiyk in 40 heavily treatment-experienced patients with MDR HIV-1 who continued to have high levels of virus (HIV-RNA) in their blood despite being on 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,” said Jeff Murray, M.D., deputy director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research in a press release
The majority of participants in the trial had previously been treated with 10 or more antiretroviral drugs, and many experienced a substantial reduction in their HIV-RNA levels one week after the newly-approved therapy was added to their failing regimens.
“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 medication is administered intravenously once every 2 weeks and is intended to be used in combination with other antiretroviral medications.
Previously, the FDA had granted this application Fast Track, Priority Review and Breakthrough Therapy designations. Additionally, ibalizumab-uiyk had received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.
Among the side effects reported in patients who receieved ibalizumab-uiyk were: diarrhea, dizziness, nausea, and rash. Severe side effects included rash and changes to the immune system.
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