Trogarzo Approved to Treat Multidrug Resistant HIV
March 6, 2018 – The U.S. FDA has approved Trogarzo™ (ibalizumab-uiyk), manufactured by Theratechnologies. A new type of antiretroviral medication, Trogarzo is indicated to treat adult patients who have multidrug resistant (MDR) HIV, and have tried multiple HIV medications in the past. It is the first HIV therapy with a new mechanism of action to receive FDA approval in the past decade.
Currently, patients with MDR HIV face limited treatment options and a high risk for potentially fatal complications of HIV infection. Trogarzo offers a new avenue for these patients to improve outcomes. Recommended dosing is once every 14 days by intravenous infusion. Patients receive a loading dose of 2,000mg for their first treatment, and an 800mg maintenance dose at each subsequent treatment. Trogarzo must be administered by a trained medical professional, and is used in conjunction with other antiretroviral medications.
FDA approval was based on a clinical trial in which 43% of participants, many of whom had previously tried 10 or more antiretroviral treatments, achieved HIV RNA suppression after two months on Trogarzo. The drug works by binding to CD4+ receptors on host cells, which allows it to block the HIV virus from infecting those cells.
Theratechnologies plans to launch Trogarzo in April of 2018. The drug is expected to cost approximately $118,000 per year, and the manufacturer has announced plans for a patient assistance program.
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