The AIDS Beacon™

In a 16-0 vote yesterday, a U.S. Food and Drug Administration (FDA) advisory committee recommended that the drug tesamorelin be approved for the treatment of HIV-associated lipodystrophy.

Although the FDA is not required to follow the recommendations of its advisory committees, it usually does.

Tesamorelin is being developed by Montreal-based Theratechnologies Inc. If approved, the drug would be marketed in the United States by EMD Serono, a unit of the German pharmaceutical company Merck KGaA. The proposed brand name for tesamorelin is Egrifta.

“I think that it’s a good day for us and I think that…

An expert advisory committee of the U.S. Food and Drug Administration (FDA) voted unanimously today to recommend approval of tesamorelin.

Tesamorelin, also known by its proposed brand name Egrifta, is being reviewed by the FDA as a potential treatement for HIV-associated lipodystrophy, an excess accumulation of abdominal fat that is a frequent side effect of antiretroviral therapy. 

Tesamorelin has been developed by the Montreal-based biopharmaceutical company Theratechnologies.  If approved by the FDA as a treatment for lipodystrophy, the drug would be marketed in the U.S. by EMD Serono, a unit of the German pharmaceutical company Merck…

The U.S. Food and Drug Administration (FDA) will hold an advisory committee meeting today in regard to the new drug application for tesamorelin (proposed brand name: Egrifta).  The AIDS Beacon will be providing live updates on the meeting as it progresses.

The Montreal-based biopharmaceutical company Theratechnologies is seeking FDA approval to market tesamorelin as a treatment for HIV-associated lipodystrophy, an excess accumulation of abdominal fat that is a frequent side effect of antiretroviral therapy.

During its meeting today, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will review data…

On Tuesday, March 22, the Centers for Medicare & Medicaid Services (CMS) announced an expansion of current policy to cover facial injections for beneficiaries suffering from hollowed cheeks as a result of HIV treatment.

Hollowed cheeks result from a condition known as facial lipodystrophy syndrome (LDS). LDS is a combination of localized fat loss (lipoatrophy), localized fat gain (lipodystrophy), and other metabolic abnormalities.

When highly active antiretroviral therapy (HAART) was introduced in the 1990s, patients began to experience LDS as a side effect of the therapy. Currently 13 to 38…

Tesamorelin, a growth hormone-releasing compound, successfully reduced abdominal fat in HIV-positive subjects by approximately 18 percent, according to a new study published in the Journal of Acquired Immune Deficiency Syndromes (JAIDS).

Excess abdominal fat accumulation, also called lipohypertrophy, is one of the potential side effects of antiretroviral therapy (ART). Tesamorelin, a new drug candidate, may be able to counteract this common problem among HIV patients.

The clinical trial took place over 12 months among 404 HIV-positive individuals with excess abdominal fat as a result of ART. Some patients were given…

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…

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…

A recent study published on the Web site PloS One implicates Combivir (zidovudine/lamivudine) in “limb fat loss,” a common side effect of treatment for HIV infection. In a clinical trial conducted by researchers in the Netherlands, Combivir-containing therapy was associated with localized loss of fat tissue and build up of internal fat tissue in the stomach. These findings support using alternatives to Combivir as preferred components of antiretroviral treatment.

Combivir (zidovudine/lamivudine) is a combination therapy that includes zidovudine (Retrovir) and Epivir (lamivudine). Both zidovudine and Epivir are nucleoside reverse transcriptase…