Theratechnologies Receives FDA Approval For Intravenous Push Administration Of Trogarzo

(RTTNews) - Theratechnologies Inc. (THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, has received FDA approval for the intravenous push mode administration of its antiretroviral medication Trogarzo for the treatment of HIV-1 infection in multidrug-resistant patients.

The approval of the Trogarzo was based on a phase III TMB-302 trial, which demonstrated that the safety and pharmacokinetic profile of Trogarzo administered via intravenous push are similar to that of intravenous infusion administration.

Trogarzo was originally approved by the FDA, in 2018, to be administered intravenously as a single loading dose followed by a 15-minute maintenance dose every two weeks for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in multidrug-resistant patients.

Trogarzo is a long-acting, CD4-directed, post-attachment HIV-1 inhibitor.

The intravenous push mode of administration reduces the time of administration of the maintenance dose from 15 minutes to 30 seconds.

For the second quarter ended May 31, 2022, net sales of Trogarzo were $7.85 million compared to $7.4 million in the year-ago period.

According to HIV.gov, approximately 1.2 million people in the U.S. suffer from HIV.

THTX has traded in a range of $1.89 to $3.73 in the last 52 weeks. The stock closed Monday's trading at $2.30, down 9.13%