US- Theratechnologies Submits sBLA for IV Push Trogarzo (ibalizumab) for Multidrug Resistant HIV-1

Theratechnologies announced the submission of a sBLA to the FDA for the Company’s intravenous (IV) push form of administration of Trogarzo.

As recently announced (Press Release), TMB-302 study demonstrated that there was no difference in pharmacokinetics (PK) between IV Push and IV Infusion and was conducted by the Company’s partner, TaiMed Biologics (TaiMed). Trogarzo IV Push, a more convenient form of administration, can be infused within 30 seconds without dilution compared to the 15-minute infusion time of the original IV Infusion. Theratechnologies believes this mode of administration will represent a marked improvement for patients.

Additionally, TMB-302 also 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. There were also no anti-Trogarzo antibodies or immunogenicity concerns of Trogarzo detected.