On June 1, 2009, Theratechnologies Inc. filed a New Drug Application (NDA) with the United States Food and Drug Administration (FDA) for tesamorelin. Tesamorelin is used to treat excess fat buildup in HIV-infected patients.

The results of a Phase 3 clinical trial affirmed that tesamorelin reduces fat accumulation around internal organs (known as visceral fat) in patients with HIV-associated lipodystrophy.

Lipodystrophy is a condition that causes changes in an individual’s fat distribution throughout the body. Changes in fat distribution can lead to changes in body shape, and can also cause cardiovascular disease.

Lipodystrophy can cause changes in the amount of lipids in the blood (known as dislipidemia) as well as glucose intolerance. People with glucose intolerance have normal blood glucose levels while fasting, but experience sharp increases in blood glucose levels as they eat. Disorders related to glucose intolerance include diabetes.

Prior research has found that patients with lipodystrophy also have low levels of growth hormone, a hormone secreted by the pituitary gland that controls growth and metabolism in the body.

Tesamorelin is a modified version of growth hormone-releasing factor, which stimulates the production of growth hormone while preventing side effects such as the fluctuation of glucose and insulin levels. The drug has a long period of activity, so that it requires one subcutaneous injection per day.

Before tesamorelin can be approved for use in the United States, the FDA will proceed through a thorough review of the NDA to ensure the drug is safe and effective.

For more information, please see the Theratechnologies press release.