On January 25th, Theratechnologies, a Canadian biopharmaceutical company, announced that the United States Food and Drug Administration (FDA) is postponing the meeting of Endocrinologic and Metabolic Drugs Advisory Committee to review Theratechnologies’ New Drug Application (NDA) for tesamorelin. According to the FDA, the reason for postponement is due to procedural reasons and is unrelated to the NDA for tesamorelin.

In 2008, Theratechnologies completed a Phase III clinical trial for tesamorelin and found that it was effective in reducing excessive abdominal fat accumulation caused by lipodystrophy in HIV-infected patients. Supported by these positive findings, Theratechnologies submitted an NDA for tesamorelin to the FDA in May 2009 (see related AIDS Beacon news).

HIV-related lipodystrophy is characterized by changes in fat distribution throughout the body, such as excess abdominal fat accumulation, dyslipidemia (disruption in the amount of lipids in the body), and glucose intolerance. There are several causative factors of lipodystrophy in HIV patients, including the patient’s antiretroviral therapy (ART) regimen (see related AIDS Beacon news) and the HIV virus itself.

In addition to affecting one’s body shape, HIV-related lipodystrophy also can have a severe negative impact on an individual’s perception of his/her body image. In a recent study in AIDS Patient Care and STDs, researchers found that HIV-patients undergoing intensive ART often undergo significant physical body changes that may lead to a heavy psychological burden. In the study, the most commonly reported body change issues were lipoatrophy (localized loss of fat tissue) and lipohypertrophy (bulging of an area due to fat accumulation). The patients reported that these conditions negatively affected their daily activities.

The study recommends that physicians take this psychological effect into account when prescribing regimens to patients because it may affect how closely the patient chooses to follow the regimen. For example, ART medications such as stavudine (Zerit) are commonly prescribed to patients because of its lower cost. However, the World Health Organization recently recommended ending the use of stavudine as first line treatment because it causes lipodystrophy (see related AIDS Beacon news).

The pending approval of Theratechnologies’ tesamorelin is crucial because the drug serves as a beneficial solution to the AIDS society by reducing lipodystrophy and related psychological issues.

For more information, please see Theratechnologies’s press release.