Trogarzo® (ibalizumab-uiyk) injection
Trogarzo® is a long-acting monoclonal antibody which binds to domain 2 of the CD4 T cell receptors. It blocks viral entry into host cells while preserving normal immunologic function. Trogarzo® belongs to the CD4-directed post-attachment HIV-1 inhibitor class of antiretrovirals. In the United States, Trogarzo® is approved, in combination with other antiretroviral(s), for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug resistant (MDR) HIV-1 infection failing their current antiretroviral regimen. Trogarzo® has been approved in the US since March 2018 and was the first intravenous agent approved for the treatment of HIV-1 infection.
Patients with MDR HIV-1 may eventually progress to AIDS and become susceptible to many opportunistic infections that ultimately lead to disability and death.
Trogarzo®, in combination with other agents, could provide patients better virologic control of their condition and ultimately reduce the risk of clinical events.
It is estimated that there are between 20,000 and 25,000 patients with MDR HIV-1 in the United States. In Europe, the number of patients with MDR HIV-1 is estimated at 35,000.
Trogarzo® was approved by the European Commission on September 26, 2019. It is commercialized in Germany and is available through special access programs in many European countries such as France, Italy and Spain.