THTX - Theratechnologies Submits sBLA for Trogarzo® Intramuscular (IM) Method of Administration to FDA | Benzinga
- Trogarzo® IM maintenance dosing aims to further enhance the convenience of non-oral therapy for heavily treatment-experienced adults with HIV
- Submission comes on the heels of the recent FDA approval of the Trogarzo® IV push loading dose
| This news release constitutes a "designated news release" for the purposes of the Company's prospectus supplement dated December 16, 2021 to its short form base shelf prospectus dated December 14, 2021. |
MONTREAL, Jan. 02, 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. ("Theratechnologies" or the "Company") (TSX:TH) (NASDAQ:THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today announced that the Company has filed a supplemental Biologics License Application (sBLA) for an intramuscular (IM) method of administration for the maintenance dose of Trogarzo® (ibalizumab-uiyk) to the United States Food and Drug Administration (FDA) for review. In the U.S., Trogarzo®, in combination with other antiretrovirals (ARVs), is indicated for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current ARV regimen.
The Trogarzo® IM sBLA submission follows the recent FDA approval of the Company's Labelling Prior Approval Supplement to include a 2,000-mg intravenous (IV) push loading dose, which can now be delivered in as little as 90 seconds and no longer requires treatment to be initiated in specialized infusion clinics. The potential addition of an entirely new method of administration for the maintenance dose via a rapid IM injection every two weeks could further simplify the Trogarzo® treatment regimen.
"The intramuscular method of administration, if approved for the maintenance dose, will give patients and their health care providers more options for Trogarzo® treatment and without the need for regular IV placement," said Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer at Theratechnologies. "Our vision through the introduction of IV push administration and, hopefully soon, IM administration, is that Trogarzo® treatment will be a less invasive and more convenient proposition for heavily treatment-experienced adults with HIV, a population that has long had limited non-oral treatment options."
In accordance with the FDA's filing review period, Theratechnologies expects to receive an acknowledgment letter of the sBLA application within 30 days along with a Prescription Drug User Fee Act (PDUFA) goal date.
About Trogarzo®
Trogarzo® (ibalizumab-uiyk) is a long-acting, CD4-directed, post-attachment HIV-1 ...