On March 06, 2018, the United States Food and Drug Administration (USFDA) approved Trogarzo (Ibalizumabuiyk), 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). Trogarzo is administered intravenously once every 14 days by a trained medical professional and used in combination with other antiretroviral medications38.
The FDA granted approval of Trogarzo to TaiMed Biologics. Earlier, the FDA had granted this application Fast Track, Priority Review and Breakthrough Therapy designations. Trogarzo had also received Orphan Drug designation from the agency, a designation that provides incentives to assist and encourage the development of drugs for rare diseases.
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 undergone multiple HIV drugs therapies, develop multidrug resistant HIV, limiting their treatment options and putting them at a high risk of HIV-related complications and progression to death. Trogarzo is the first drug in a new class of antiretroviral medications that can provide significant benefits to patients who have run out of HIV treatment options. This new treatment option may be able to improve their outcomes.
Trogarzo represents a critical new treatment advancement as the first HIV therapy with a new mechanism of action approved in 10 years and proven effectiveness in difficult-to-treat patients with limited options. Unlike all other classes of ARTs, Trogarzo is a CD4- directed post-attachment HIV-1 inhibitor that binds to CD4+ receptors on host cells and blocks the HIV virus from infecting the cells. In combination with other Anti-retroviral treatments (ARTs), Trogarzo is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen39.
The safety and efficacy of Trogarzo were evaluated in a clinical trial of 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. Many of the participants had previously been treated with 10 or more antiretroviral drugs. The majority of participants experienced a significant decrease in their HIV-RNA levels one week after Trogarzo was added to their failing antiretroviral regimens. After 24 weeks of Trogarzo plus other antiretroviral drugs, 43 percent of the trial's participants achieved HIV RNA suppression.
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 (immune reconstitution syndrome).
About Trogarzo
Trogarzo (Ibalizumab) is a humanized monoclonal antibody for the treatment of multidrug resistant HIV-1 infection. Trogarzo binds primarily to the second extracellular domain of the CD4+ T receptor, away from major histocompatibility complex II molecule binding sites. It prevents HIV from infecting CD4+ immune cells while preserving normal immunological function. Trogarzo blocks HIV from infecting certain cells of the immune system. This prevents HIV from multiplying and can reduce the amount of HIV in the body.
Conclusion:
The approval of Ibalizumab represents potentially a critical new treatment advancement in difficult-to-treat patients with multi drug resistant HIV.
Footnotes
38 https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm599657.htm
39 https://theratechnologies.s3.amazonaws.com/prod/media/Press-release-FDA-Approval-V18-E-Canada-Final.pdf
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