- Theratechnologies Inc. (TH) has submitted o a supplemental biologics license application (sBLA) to the U.S. FDA for its IV push form of administration of Trogarzo
- Trogarzo IV Push can be infused within 30 seconds without dilution compared to the 15-minute infusion time of the original IV Infusion
- A study demonstrated that there was no difference in pharmacokinetics between IV Push and IV Infusion and was conducted by TaiMed Biologics
- No anti-Trogarzo antibodies or immunogenicity concerns were detected
- Theratechnologies Inc. (TH) is up 4.35 per cent and is trading at $4.08 per share as of 3:51 p.m. EST
Theratechnologies (TH) has submitted a supplemental biologics license application (sBLA) to the U.S. FDA for its IV push form of administration of Trogarzo.
Trogarzo is a CD4-directed post-attachment HIV-1 inhibitor.
The IV Push Trogarzo program continues Theratechnologies’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 the Trogarzo IV Push program.
A study demonstrated that there was no difference in pharmacokinetics between IV Push and IV Infusion and was conducted by the company’s partner, TaiMed Biologics.
Trogarzo IV Push 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.
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 achieved confirming no difference in HIV-1 viral load due to the change from IV Infusion to IV Push.
No anti-Trogarzo antibodies or immunogenicity concerns were detected.
In Europe, Trogarzo is approved for the treatment of adults infected with MDR HIV-1 for whom it is otherwise not possible to construct a suppressive antiviral regimen.
Theratechnologies Inc. (TH) is up 4.35 per cent and is trading at $4.08 per share as of 3:51 p.m. EST.