- Theratechnologies Inc. (TH) has received U.S. Food and Drug Administration (FDA) approval for its Trogarzoto to be administered by IV therapy
- Trogarzo is a long-acting, immune cell-directed, post-attachment HIV-1 inhibitor
- Following today’s approval, the maintenance dose can be administered as an undiluted IV push over 30 seconds
- Trogarzo is also being studied for intramuscular injection administration
- Theratechnologies Inc. (TH) is down 4.27 per cent, trading at $3.14 per share as of 3:52 p.m. ET
Theratechnologies (TH) has received U.S. Food and Drug Administration (FDA) approval for its Trogarzo to be administered by IV therapy.
Trogarzo is a long-acting, immune cell-directed, post-attachment HIV-1 inhibitor. In the U.S., it is used in combination with other antiretrovirals (ARVs) for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant viruses failing their current ARV regimen.
The FDA originally approved Trogarzo in March 2018 to be administered intravenously as a single loading dose followed by a 15-minute maintenance dose every two weeks. Following today’s approval, the maintenance dose can be administered as an undiluted IV push over 30 seconds.
Dr. Christian Marsolais, Chief Medical Officer of Theratechnologies, commented
“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… to bring much needed non-oral innovations to help shift the treatment paradigm for heavily treatment-experienced people living with HIV.”
The approval is based on study TMB-302, a phase three trial that evaluated the safety and pharmacokinetic profile of an 800-milligram dose of Trogarzo once every two weeks. Results showed the profile of Trogarzo administered via IV push is similar to IV infusion administration.
Trogarzo is also being studied for intramuscular injection administration in the TMB-302 study. The study is now fully enrolled, with the last patient visit scheduled for next month.
Theratechnologies Inc. (TH) is down 4.27 per cent, trading at $3.14 per share as of 3:52 p.m. ET.