Theratechnologies Submits Updated Tesamorelin F8 Formulation sBLA for FDA Review

Core Points - Theratechnologies Inc. has resubmitted its supplemental Biologics License Application (sBLA) for the F8 formulation of tesamorelin to the FDA, aiming to simplify dosing for the treatment of excess abdominal fat in adults with HIV and lipodystrophy [1][2] - The resubmission addresses concerns raised in the FDA's Complete Response Letter (CRL) issued in January 2024, which primarily focused on chemistry, manufacturing, and controls (CMC), as well as immunogenicity risk [2] - The FDA is expected to review the updated sBLA within four months, with a decision anticipated around the end of March 2025 [3] Product Information - EGRIFTA SV® (tesamorelin for injection) is currently approved in the U.S. for reducing excess abdominal fat in HIV-infected adult patients with lipodystrophy [4] - EGRIFTA SV® functions as a growth hormone releasing factor (GHRF) analog, stimulating the production and release of endogenous growth hormone [4] Company Overview - Theratechnologies is a biopharmaceutical company focused on developing and commercializing innovative therapies to address unmet medical needs [8]