The US Food and Drug Administration (FDA) has approved Trogarzo (ibalizumab), a new antiretroviral medication for multidrug-resistant HIV (MDR-HIV).
TaiMed Biologics submitted the application for FDA marketing approval for Trogarzo in May 2017. The new treatment is marketed at adult patients who have found existing HIV medications ineffective. HIV drug resistance occurs when there are pauses in treatment, allowing the virus time to mutate and become resistant to antiretroviral therapy.
“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 the director of FDA’s Division of Antiviral Products Jeff Murray.
“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.”
Trogarzo is given intravenously once every 14 days and used in combination with other antiretroviral medications. A clinical trial reported positive results when examining the efficacy and safety of Trogarzo, focusing on a small patient population with limited treatment options.
The study enrolled 40 treatment-experienced patients with MDR HIV-1, many of whom had been previously treated with 10 or more antiretroviral drugs yet continued to show high levels of the virus HIV-RNA in their bloodstream. The study found that a majority of participants experienced a significant decrease in their HIV-RNA levels one week after they were given Trogarzo in combination with their failing antiretroviral regimes.
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Following 24 weeks of Trogarzo in addition to other antiretroviral drugs, 43% of participants achieved HIV-RNA suppression. The most common side effects to the drug were diarrhoea, dizziness, nausea and rash. Severe side effects included rash and immune reconstitution syndrome.
Trogarzo received fast track, priority review and breakthrough therapy designations from the FDA. It was also granted the Orphan Drug designation, which is designed to incentivise the development of drugs for rare diseases.
Preventing and managing MDR-HIV has gained increased attention over the past few years. In July 2017, the World Health Organisation (WHO) released three major reports addressing HIV drug resistance. These included new treatment guidelines, a Global Action Plan, and the first global report on HIV drug resistance (HIVDR) since 2012.
The Action Plan focused on five strategic objectives, aiming to tackle HIVDR through effective monitoring, research and innovation, increasing laboratory capacity, prevention and response, and governance and enabling mechanisms. It will attempt to achieve these objectives between 2017 and 2021, aiming to collaborate with global partners, donors and researchers to address drug resistance, particularly in low and middle income countries.