EMD Serono received FDA approval for Egrifta (tesamorelin for injection) as a treatment to reduce excess abdominal fat in HIV-infected patients with lipodystrophy. The drug was developed by Theratechnologies, a Canadian biopharmaceutical company, and will be marketed in the U.S. exclusively by EMD Serono.
The FDA requested the following three postmarketing requirements: a long-term observational safety study, the development of a new presentation for a single-vial formulation, and a clinical trial to assess whether Egrifta has an impact on diabetic retinopathy in diabetic HIV-infected patients with lipodystrophy and excess abdominal fat.
“As HIV-infected patients are living longer, a substantial number may develop metabolic complications associated with HIV, such as abdominal lipohypertrophy,” remarks Morris Schambelan, M.D., professor of medicine, University of California, San Francisco.
There are limitations to using Egrifta, EMD cautions. Since the long-term cardiovascular safety and potential long-term cardiovascular benefit of the medication have not been studied, careful consideration should be given whether to continue Egrifta treatment in patients who do not show a clear efficacy response as judged by the degree of reduction in visceral adipose tissue (VAT) measured by waist circumference (WC) or CT scan.
Egrifta was evaluated in two Phase III multicenter, randomized, double-blind, placebo-controlled trials. They consisted of a 26-week main phase and a 26-week extension phase and enrolled 816 HIV-infected patients with excess abdominal fat associated with lipodystrophy. Patients initially randomized to receive Egrifta were then re-randomized to receive either Egrifta or placebo for an additional 26-week treatment period, whereas patients receiving placebo were switched to Egrifta.
The primary endpoint of the 26-week main phase was the percent change in VAT from baseline, as assessed by computed tomography (CT) scan at the L4-L5 vertebral level. Both trials demonstrated statistically significant decreases in VAT and WC versus placebo in HIV-infected patients who suffer from excess abdominal fat associated with lipodystrophy.