Theratechnologies Receives FDA Approval for EGRIFTA WR™ (Tesamorelin F8) to Treat Excess Visceral Abdominal Fat in Adults with HIV and Lipodystrophy

Core Viewpoint - Theratechnologies Inc. has received FDA approval for the new formulation of tesamorelin, named EGRIFTA WR™, which is set to replace the existing EGRIFTA SV formulation, offering improved convenience and patient experience [2][3][5]. Company Overview - Theratechnologies is a commercial-stage biopharmaceutical company focused on innovative therapies, with its stock listed on TSX and NASDAQ [10]. Product Details - EGRIFTA WR™ is the only FDA-approved medication for reducing excess abdominal fat in adults with HIV-related lipodystrophy [3]. - The new formulation requires less than half the administration volume compared to the previous EGRIFTA SV, which necessitated daily reconstitution [3]. - EGRIFTA WR™ is supplied in four single-patient-use vials, each containing 11.6 mg of tesamorelin, sufficient for seven doses, with a daily dose of 1.28 mg [4]. - The product can be stored at room temperature before and after reconstitution [4]. Clinical Significance - Central adiposity is a common complication for people with HIV, and the new formulation aims to address this issue effectively [5]. - The new formulation is expected to enhance patient compliance and experience in managing comorbidities associated with HIV [4][5]. Manufacturing and Patent Information - EGRIFTA WR™ will be manufactured at a new U.S.-based contract drug manufacturing organization (CDMO) [5]. - The formulation is patent protected in the U.S. until 2033 [5].