Theratechnologies FDA OK to Treat Excess Visceral Abdominal Fat in HIV and Lipodystrophy

 New, improved formulation set to replace EGRIFTA SV®

Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a commercial-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s supplemental Biologics License Application (sBLA) for the F8 formulation of tesamorelin for injection. The Company will commercialize the new formulation under the tradename EGRIFTA WR™.

Tesamorelin for injection is the only medication approved in the U.S. for the reduction of excess abdominal fat in adults with HIV who have lipodystrophy. The new formulation, EGRIFTA WR™, is a daily injectable but only needs weekly reconstitution. It requires less than half the administration volume as the current F4 formulation, sold in the U.S. as EGRIFTA SV®, which is reconstituted daily. Pharmacokinetic studies have shown bioequivalence of EGRIFTA WR™ to the original F1 formulation of tesamorelin for injection (previously sold under the trade name EGRIFTA®). The most commonly reported adverse reactions of EGRIFTA WR™ include arthralgia, injection site reactions, pain in extremity, peripheral edema, and myalgia.

https://www.globenewswire.com/news-release/2025/03/25/3049233/0/en/Theratechnologies-Receives-FDA-Approval-for-EGRIFTA-WR-Tesamorelin-F8-to-Treat-Excess-Visceral-Abdominal-Fat-in-Adults-with-HIV-and-Lipodystrophy.html