November 11, 2010
Egrifta approved for HIV-associated abdominal lipodystrophyMerck and EMD Serono announced that the FDA has approved Egrifta (tesamorelin for injection), a growth hormone releasing factor (GRF) analog, for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. This approval was based on data from two Phase 3 multicenter, randomized, double-blind, placebo-controlled trials which demonstrated significant decreases in visceral adipose tissue (VAT) and waist circumference versus placebo in 816 HIV-infected patients who suffer from excess abdominal fat associated with lipodystrophy.
Patients treated with Egrifta experienced a statistically significant least-squares mean decrease from baseline in VAT of 27cm2 compared to an increase of 4cm2 for patients on placebo [(95% CI for the mean treatment difference of -31cm2 (-39cm2, -24cm2)] in the first study, and a statistically significant decrease from baseline in VAT of 21cm2 compared to no change in VAT for patients on placebo [(95% CI for the mean treatment difference of -21cm2 (-29cm2, -12cm2)] in the second study during the 26-week main phase.
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