FDA

FDA OKs new formulation of tesamorelin for HIV-related lipodystrophy

April 4, 2025

FDA approved a new, more concentrated formulation (F8) of tesamorelin for injection to be marketed under the tradename Egrifta WR.

The new formulation, which requires less than half the administration volume as the current F4 formulation (Egrifta SV), is a daily injectable that only needs weekly reconstitution. The original formulation of Egrifta required daily reconstitution.

Efficacy

Safety and effectiveness of Egrifta WR (11.6 mg/vial formulation) has been established based on well-controlled studies with Egrifta (1 mg/vial formulation) as well as a demonstration of comparable bioavailability between the 1.28 mg Egrifta WR dose (11.6 mg/vial formulation) and the 2 mg Egrifta dose (1 mg/vial formulation).

Safety

The most commonly reported adverse reactions include arthralgia, injection site reactions, extremity pain, peripheral edema, and myalgia.

Sources:

Egrifta WR (tesamorelin) [package insert]. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022505s020lbl.pdf Revised March 2025. Accessed April 2, 2025.

Theratechnologies receives FDA approval for Egrifta WR™ (tesamorelin F8) to treat excess visceral abdominal fat in adults with HIV and lipodystrophy. [News release]. 2025. https://www.theratech.com/news-releases/news-release-details/theratechnologies-receives-fda-approval-egrifta-wrtm-tesamorelin