Theratechnologies Receives FDA Approval of Prior Approval Supplement (PAS) for EGRIFTA SV® sBLA

Core Insights - The FDA has approved Theratechnologies' Prior Approval Supplement (PAS) for EGRIFTA SV®, allowing unrestricted distribution and removing previous supply uncertainties [1][2][3] - The new formulation, EGRIFTA WR™, has also been approved by the FDA and is set to replace EGRIFTA SV® in the U.S. market [2][3] Company Overview - Theratechnologies Inc. is a commercial-stage biopharmaceutical company focused on innovative therapies, particularly for HIV-related conditions [1][8] - The company aims to improve patient experience with the new EGRIFTA WR™ formulation, which is designed to be more convenient [3] Product Information - EGRIFTA SV® (tesamorelin for injection) is the only FDA-approved treatment for reducing excess abdominal fat in adults with HIV and lipodystrophy [1][3] - Tesamorelin acts as a growth hormone-releasing factor (GHRF) analog, stimulating the production and release of endogenous growth hormone [3] Regulatory Developments - The approval of the PAS eliminates the need for discretionary product release, enabling the company to resume regular distribution of EGRIFTA SV® [2] - The transition to EGRIFTA WR™ is anticipated to enhance patient compliance and overall treatment experience [3]