approval trial2010
Two multicenter, randomized, double-blind, placebo-controlled Phase 3 trials in 816 HIV-infected adults with lipodystrophy (Study 1, n=412; Study 2, n=404) found 26-week VAT changes of -18% vs +2% with placebo (Study 1) and -14% vs -2% (Study 2) with tesamorelin 2 mg daily.
816 HIV-infected adults with lipodystrophy-associated excess abdominal fat
approval trial2010
FDA approved Egrifta (tesamorelin for injection) on November 10, 2010, as the first treatment for reduction of excess abdominal visceral fat in HIV-associated lipodystrophy.
HIV-infected adults with lipodystrophy
approval trial2010
Tesamorelin treatment was associated with an increased risk of new-onset diabetes (HbA1c >=6.5%) relative to placebo (hazard/odds ratio ~3.3) in the pivotal trial program.
HIV-infected adults with lipodystrophy
approval trial2025
FDA approved a more concentrated F8 formulation (EGRIFTA WR) on March 25, 2025, requiring only weekly reconstitution and less than half the injection volume of the prior EGRIFTA SV (F4) formulation.
HIV-infected adults with lipodystrophy
approval trial2010
Egrifta labeling requires monitoring for recurrence of malignancy and periodic IGF-1 monitoring given the drug's mechanism of raising growth-hormone-axis activity, and states that the effects of prolonged IGF-1 elevation are unknown.
HIV-infected adults with lipodystrophy