FDA Approves Tesamorelin (Egrifta) for Management of Lipodystrophy in People with HIV

The U.S. Food and Drug Administration (FDA) this week approved the growth hormone releasing factor tesamorelin (brand name Egrifta, formerly TH9507) for treatment of lipodystrophy, or excess body fat accumulation, in HIV positive people taking antiretroviral therapy (ART). Developed by Theratechnologies, the drug will be marketed in the U.S. by EMD Serono. Clinical trials showed that tesamorelin significantly reduced abdominal fat with fewer side effects than human growth hormone itself, though fat returned when the drug was discontinued.

Abdominal fat accumulation or lipohypertrophy is a concern for many people with HIV, related to both body image and increased cardiovascular risk; it may also compromise the effectiveness of HIV treatment by contributing to poor ART adherence. Human growth hormone has been shown to reduce visceral adipose tissue (fat deep in the abdomen surrounding internal organs), but it can lead to side effects including elevated blood glucose, swelling, and carpal tunnel syndrome.

Tesamorelin is a synthetic growth hormone releasing factor that stimulates the pituitary gland in the brain to secrete more growth hormone; this indirect approach appears to maintain more stable, natural levels. As reported this past spring, tesamorelin decreased visceral abdominal fat and lowered total cholesterol, and was generally well-tolerated.

Below is the text of an FDA press release describing the approval and supporting research.

FDA Approves Egrifta to treat Lipodystrophy in HIV Patients

November 10, 2010 -- The U.S. Food and Drug Administration today approved Egrifta (tesamorelin) to treat HIV patients with lipodystrophy, a condition in which excess fat develops in different areas of the body, most notably around the liver, stomach, and other abdominal organs. The condition is associated with many antiretroviral drugs used to treat HIV.

Egrifta, the first FDA-approved treatment for lipodystrophy, is a growth hormone releasing factor (GRF) drug that is administered in a once-daily injection.

"The FDA recognizes the need for therapies to treat patients with HIV-lipodystrophy," said Curtis Rosebraugh, MD, MPH, director of the Office of Drug Evaluation II in the FDA's Center for Drug Evaluation and Research. "The presence of excess fat with this condition may contribute to other health problems as well as affect a patient's quality of life, so treatments that demonstrate they are safe and effective at treating these symptoms are important."

Whether Egrifta decreases the risk of cardiovascular disease or improves compliance with antiretroviral drugs has not been studied.

Egrifta was evaluated in two clinical trials involving 816 HIV-infected adult men and women with lipodystrophy and excess abdominal fat. Of these, 543 patients received Egrifta during a 26-week, placebo-controlled period. 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). Some patients reported improvements in their self image.

The most commonly reported side effects in the studies included joint pain (arthralgia), skin redness and rash at the injection site (erythema and pruritis), stomach pain, swelling, and muscle pain (myalgia). Worsening blood sugar control occurred more often in patients treated with Egrifta than with placebo.

Egrifta was developed by Montreal-based Theratechnologies Inc. and marketed in the U.S. by Rockland, Mass.-based EMD Serono.

Product labeling information for Egrifta will be available soon on Drugs@FDA.
 

11/12/10

Source

U.S. Food and Drug Administration. FDA approves Egrifta to treat Lipodystrophy in HIV patients. Press release. November 10, 2010.