Theratechnologies’ Trogarzo Receives FDA Approval for 30-Second IV Push
Montreal, Canada-based Theratechnologies has received FDA’s approval for Trogarzo (ibalizumab-uiyk) for administration by intravenous (IV) push.
The drug was first approved in March 2018 and used in combination with other antiretroviral(s) for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection who are failing their current antiretroviral regimen.
The newly approved method uses the undiluted medication injected by IV push in 30 seconds. When first approved, the drug was administered as a single infusion loading dose followed by a 15-minute maintenance dose every two weeks.
This approval was supported by a phase 3 study in which the drug’s pharmacokinetic and safety profile administered by IV push were shown to be similar to that of IV infusion administration. The drug is currently being studied for intramuscular injection.
October 10, 2022
