Theratechnologies claimed that Egrifta, the first FDA-approved treatment for lipodystrophy, is a growth hormone releasing factor (GRF)drug that is administered in a once-daily injection.
Egrifta was evaluated in two clinical trials involving HIV-infected adult men and women with lipodystrophy and excess abdominal fat.
In both studies, patients treated with Egrifta experienced greater reductions in abdominal fat as measured by CT scan, compared with patients receiving another injectable solution (placebo).
FDA Center for Drug Evaluation and Research Office of Drug Evaluation II director Curtis Rosebraugh said that the FDA recognises the need for therapies to treat patients with HIV-lipodystrophy.