Egrifta approved for HIV-associated abdominal lipodystrophy

Merck 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.

For more information call (888) 275-7376 or visit www.emdserono.com.