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FDA Okays New HIV Treatment For Those Having Limited Treatment Options

The U.S. Food and Drug Administration said it approved Trogarzo or ibalizumab-uiyk, a new type of antiretroviral medication 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. The FDA granted approval of Trogarzo to TaiMed Biologics USA Corp. The FDA granted approval of Trogarzo to TaiMed Biologics USA Corp.

Trogarzo is administered intravenously once every 14 days by a trained medical professional and used in combination with other antiretroviral medications.

The clinical trial focused on the small patient population with limited treatment options and demonstrated the benefit of Trogarzo in achieving reduction of HIV RNA. The seriousness of the disease, the need to individualize other drugs in the treatment regimen, and safety data from other trials were considered in evaluating the Trogarzo development program.

A total of 292 patients with HIV-1 infection have been exposed to Trogarzo IV infusion. The most common adverse reactions to Trogarzo were diarrhea, dizziness, nausea and rash. Severe side effects included rash and changes in the immune system.

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