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Beacon LiveNews – Tesamorelin FDA Advisory Committee Meeting

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Published: May 27, 2010 8:17 am
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 related to the efficacy and safety of tesamorelin.  The Committee, which consists of non-FDA medical experts, also will vote on whether it believes tesamorelin should be approved by the FDA.  The FDA is under no obligation to follow recommendations made by its advisory committees, but it generally does.

AIDS Beacon associate publisher Courtney McQueen will be attending and reporting on today’s meeting.  Her liveblog of the tesamorelin advisory committee meeting is available here.

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