Dr. Christian Marsolais reports

THERATECHNOLOGIES RECEIVES REFUSAL TO FILE LETTER FOR TROGARZO INTRAMUSCULAR METHOD OF ADMINISTRATION SBLA FROM FDA

The United States Food and Drug Administration (FDA) has issued a refusal-to-file letter (RTF) regarding Theratechnologies Inc.'s supplemental biologics licence application (sBLA) for an intramuscular (IM) method of administration for the maintenance dose of Trogarzo (ibalizumab-uiyk). The sBLA filing was announced on Jan. 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 Dr. Christian Marsolais, PhD, senior vice-president and chief medical officer at Theratechnologies. "We will now assess our options regarding this application."

About Theratechnologies Inc.

Theratechnologies is a biopharmaceutical company focused on the development and commercialization of innovative therapies addressing unmet medical needs.

We seek Safe Harbor.