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Pharmaceuticals / Inspections and Audits

FDA Gives Go Ahead to HIV Medication Trogarzo

March 8, 2018

The FDA approved Trogarzo (ibalizumab-uiyk) for use in patients with HIV who have tried multiple other treatments in the past and cannot use other available therapies for treatment, such as patients with multidrug resistant HIV.

Injected intravenously every two weeks by a medical professional, Trogarzo is used in conjunction with other antiretroviral medications. The drug is the first in a new class of antiretroviral medications that can offer benefits to patients who have exhausted their HIV treatment options.

Trogarzo’s safety and efficacy was assessed in a clinical trial of 40 heavily treatment-experienced patients with MDR-HIV1 who had continued to exhibit high levels of the virus in their blood despite taking antiretroviral treatments.

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