New Formulation of Tesamorelin Approved for HIV-Related Lipodystrophy

The Food and Drug Administration (FDA) has approved Egrifta WR™, a new concentrated formulation (F8) of tesamorelin, for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy.

Tesamorelin is a growth hormone-releasing factor analog that was originally approved under the brand name Egrifta®. The F8 formulation is 8 times more concentrated than Egrifta and 2 times more concentrated than the current F4 formulation, Egrifta SV®. The approval was supported by pharmacokinetic studies that showed bioequivalence between the Egrifta WR 1.28mg dose (11.6mg/vial formulation) and the Egrifta 2mg dose (1mg/vial formulation).

Each single-patient-use vial of Egrifta WR contains tesamorelin 11.6mg (equivalent to approximately 11.9mg of tesamorelin acetate); 1 reconstituted Egrifta WR vial provides daily doses for 7 consecutive days. The recommended dosage of Egrifta WR is 1.28mg (in 0.16mL of the reconstituted solution) administered subcutaneously into the abdomen once daily. The reconstituted Egrifta WR can be stored at room temperature.

Egrifta WR and Egrifta SV are not substitutable as these 2 formulations have differences in dosage, the number of vials required to prepare a dose, reconstitution instructions, and storage requirements.

“We are pleased to offer this improved, more convenient version of tesamorelin for injection to help people with HIV and their health care providers more effectively manage comorbidities like lipodystrophy, which today often presents as central adiposity,” said Christian Marsolais, PhD, Senior Vice President and Chief Medical Officer at Theratechnologies. “Egrifta WR enables a simplified administration and an improved patient experience, which are important considerations for people living with HIV.”

According to the Company, Egrifta WR is set to replace Egrifta SV.

This article originally appeared on MPR

References:

• Theratechnologies receives FDA approval for Egrifta WR™ (tesamorelin F8) to treat excess visceral abdominal fat in adults with HIV and lipodystrophy. News release. Theratechnologies. March 25, 2025. 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.
• Egrifta WR. Package insert. Theratechnologies; 2025. Accessed March 26, 2025. https://s3.us-east-1.amazonaws.com/email.operaticsites.com/thera/prescribing-information/THERA-Prescribing-Information.pdf.