Exhibit 99.1
Theratechnologies Receives Refusal to File Letter for
Trogarzo® Intramuscular
Method
of Administration sBLA from FDA
MONTREAL, February 27, 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 United States Food and Drug Administration (FDA) has issued a refusal
to file letter (RTF) regarding the Companys supplemental Biologics License Application (sBLA) for an intramuscular (IM) method of administration for the maintenance dose of Trogarzo®
(ibalizumab-uiyk). The sBLA filing was announced on January 2, 2024.
Upon preliminary review, the FDA determined that the sBLA was not
sufficiently complete to permit a substantive review. The RTF states that the sBLA did not contain the data required to establish the pharmacokinetic bridge between the IM and the intravenous infusion route of administration of Trogarzo®.
While we are disappointed to receive this letter from the FDA, we were aware that the
approval of this sBLA for Trogarzo® IM administration could be challenging based on the results shared in October
2023 from the TMB-302 study, even though viral suppression was maintained throughout the study, said Christian Marsolais, Ph.D., Senior Vice President and Chief
Medical Officer at Theratechnologies. We will now assess our options regarding this application.
About Trogarzo®
Trogarzo® (ibalizumab-uiyk)
is a long-acting, CD4-directed, post-attachment HIV-1 inhibitor. In the United States, Trogarzo®, in combination
with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen. Trogarzo® is not approved in Canada.
Trogarzo® is administered by intravenous (IV) infusion as a single loading dose of
2,000 mg followed by a maintenance dose of 800 mg every two weeks after dilution in 250 mL of 0.9% Sodium Chloride Injection, USP. The Trogarzo® loading dose can also be administered as an
undiluted IV push over 90 seconds, and the maintenance dose can be administered as an undiluted IV push over 30 seconds.
Important Safety Information
Do not receive Trogarzo® if you have had an allergic reaction to Trogarzo® or any of the ingredients in Trogarzo®. Trogarzo® can cause allergic
reactions, including serious reactions, during and after infusion. Tell your healthcare provider or nurse, or get medical help right away if you experience any symptoms of an allergic reaction. Before you receive Trogarzo®, tell your healthcare provider about all of your medical conditions, including if you are pregnant or plan to