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Articles tagged with: Tesamorelin

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[ by and | Nov 10, 2010 11:48 am | Comments Off ]
Review Of Fat Redistribution In People With HIV Finds Treatment Progress, But Many Unanswered Questions Remain

A new review finds that progress has been made in understanding and treating fat redistribution and other metabolic problems in people with HIV, but more research is necessary to understand the biology involved and the best treatment options. The review suggests that combining multiple treatment strategies may offer more successful options for combating these antiretroviral side effects.

Although highly active antiretroviral therapy (HAART) slows HIV disease progression and has helped prevent HIV-related deaths, its use can lead to a number of undesirable side effects, such as weight gain, high cholesterol…

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[ by and | May 28, 2010 4:12 am | Comments Off ]
FDA Advisory Committee Recommends Approval For Tesamorelin

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…

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[ by | May 27, 2010 4:06 pm | Comments Off ]
Beacon BreakingNews – Tesamorelin Receives Unanimous FDA Advisory Committee Backing

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…

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[ by | May 27, 2010 8:17 am | Comments Off ]
Beacon LiveNews – Tesamorelin FDA Advisory Committee Meeting

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…

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[ by | Mar 11, 2010 8:00 am | Comments Off ]
Tesamorelin Clinical Trial Reports Successful Reduction Of Fat Accumulation In HIV Patients

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…

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