Benzinga | Dec 6, 2021 11:53AM EST

Theratechnologies Submits Supplemental Biologics License Application To FDA Advancing Development Of IV Push Trogarzo For Patients Living With HIV

Theratechnologies Inc. (Theratechnologies or Company) (TSX:TH) (NASDAQ:THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, is pleased to announce the submission of a supplemental biologics license application (sBLA) to the U.S. Food and Drug Administration (FDA) for the Company's intravenous (IV) push form of administration of Trogarzo(r). The IV Push Trogarzo(r) program continues the Company's commitment to improving the lives and treatment outcomes for patients living with HIV.



The FDA submission is the next step in the advancement of Theratechnologies' Trogarzo(r) IV Push program. As recently announced, 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(r) 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(r) antibodies or immunogenicity concerns of Trogarzo(r) detected.