> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Theratechnologies sBLA for HIV Drug Administration
- URL: https://www.fdaweb.com/theratechnologies-sbla-for-hiv-drug-administration/
- Published: 2021-12-06T12:00:00.000Z
- Updated: 2026-09-14T17:24:40.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5150704

Theratechnologies has submitted a supplemental BLA for Trogarzo (ibalizumab-uiyk) and an intravenous (IV) push form of administration for treating, in combination with other antiretrovirals, human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults. The company recently announced results from the [TMB-302 study](https://www.globenewswire.com/Tracker?data=J8HpkBJCB9aubUHZlBhX3xc0FbdQNmpFocKiXyEQODhLGorWiwQd0QMUuR3pG03SALE2F5ScCxOkdal04CtVi-6GGSZnLJakvmvp2oYfbRJSbB1CA3yXh%5FMGZXjjBWwS62d2J6xzOC4OUlbDypo5w8VqCojmfywjSBYH23lFC4kJ3aj6UgydOlK%5FtFXnYOsjWTHYbsZfCxhZSbLcFJzdnw==&ref=fdaweb.com), which it says demonstrated that there was no difference in pharmacokinetics between IV push and IV infusion.

Additionally, Theratechnologies says the study demonstrated that there were no serious adverse events observed and drug-related adverse events were considered mild to moderate. “Secondary endpoints were also achieved confirming no difference in HIV-1 viral load due to the change from IV infusion to IV push,” the company says. There were also no anti-Trogarzo antibodies or immunogenicity concerns, it adds.

Theratechnologies says that if approved Trogarzo IV Push would be a more convenient form of administration because it can be infused within 30 seconds without dilution compared to the 15-minute infusion time of the original IV infusion.