Egrifta WR FDA Approval History
Last updated by Judith Stewart, BPharm on March 29, 2025.
FDA Approved: Yes (First approved November 10, 2010)
Brand name: Egrifta WR
Generic name: tesamorelin
Dosage form: Injection
Previous Name: Egrifta
Company: Theratechnologies
Treatment for: Lipodystrophy
Egrifta WR (tesamorelin) is a synthetic analogue of growth hormone releasing factor (GRF) for the treatment of excess abdominal fat in HIV patients with lipodystrophy.
- HIV-associated lipodystrophy is characterized by changes in body composition, including the accumulation of excess abdominal fat. Several factors are thought to contribute to HIV-associated lipodystrophy, including a patient's antiretroviral drug regimen and the HIV virus itself.
- Egrifta WR works to reduce visceral fat in HIV-infected patients with excess abdominal fat by stimulating the synthesis and release of endogenous growth hormone.
- Egrifta (tesamorelin F1) was first approved in 2010. It was replaced by Egrifta SV (tesamorelin F4), which was approved in 2019.
- Egrifta WR (tesamorelin F8) was approved in 2025 as the replacement for Egrifta SV. Egrifta WR is reconstituted weekly for daily injection. It requires less than half the administration volume as Egrifta SV, which was reconstituted daily for daily injection. Egrifta WR and Egrifta SV are not substitutable due to differences in strength, dosage, the number of vials required to prepare a dose, reconstitution instructions, and storage requirements.
- Egrifta WR is administered by subcutaneous injection into the abdomen once daily.
- Commonly adverse reactions (>5%) include arthralgia, injection site erythema, injection site pruritus, pain in extremity, peripheral edema, and myalgia.
Development timeline for Egrifta WR
Further information
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