FDA Approves New Administration Method for Trogarzo in HIV

The FDA has approved Thera Technologies’ “push” administration of Trogarzo (ibalizumab-uiyk) to treat patients with human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults. Trogarzo was approved for administration by intravenous (IV) push, a method in which the undiluted medication is pushed by syringe for faster administration into the body’s circulation. This method reduces the maintenance dose from a 15-minute IV infusion to a 30-second, undiluted IV push every two weeks.

The FDA originally approved Trogarzo, a long-acting monoclonal antibody, in March 2018 to be administered intravenously as a single loading dose followed by a maintenance dose every two weeks.

“The evolution of Trogarzo administration from intravenous infusion to intravenous push means less preparation and treatment time in clinics for patients and their health care providers, possibly allowing for more clinics to administer this treatment,” Nelson Vergel, founder of the Program for Wellness Restoration (PoWeR), said in a press release.

This new approval was based on study TMB-302, a phase 3 trial that evaluated the safety and pharmacokinetic (PK) profile of an 800-mg dose of Trogarzo once every two weeks administered via IV push. Results show that the safety and PK profile are similar to that of IV infusion administration. The safety profile of the push administration is similar to that of IV infusion.

These findings were observed in the phase 3 TMB-301 trial, which evaluated the safety and efficacy of Trogarzo in treatment-experienced patients with multidrug-resistant HIV-1. In the TMB-301 trial, patients receiving Trogarzo, in combination with other ARVs, experienced significant reductions in viral load and a clinically significant increase in CD4+ (T-cell) count. A total of 350 subjects have received Trogarzo in the clinical development program, including 19 subjects who received Trogarzo via IV push.

Trogarzo is also being studied for intramuscular injection administration in the continuation of the TMB-302 study. The study is now fully enrolled, with the last patient visit scheduled for November 2022.