March 22, 2010

HIV Lipo Treatment Egrifta to Be Reviewed May 27

A U.S. Food and Drug Administration (FDA) independent advisory committee is set to review Montreal-based Theratechnologies’ New Drug Application (NDA) for Egrifta (tesamorelin) for the treatment of HIV-associated fat increases (lipohypertrophy), according to an announcement from the Office of the Federal Register. The meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) to review the supporting safety and efficacy data is scheduled for May 27 at the University of Maryland University College in Adelphi.

Should EMDAC recommend Egrifta be approved, the FDA has until the end of July to decide whether to grant marketing clearance for the drug. Though the agency is not required to follow the recommendations of its advisory committees, it usually does.

Egrifta prompts the pituitary gland to release more growth hormone, which has been shown to promote fat loss in people with lipohyertrophy. Two completed Phase III clinical trials of Egrifta showed a decrease in visceral adipose tissue (VAT)—fat deep within the belly—of up to 18 percent and a favorable side effect profile.

Should the FDA approve Egrifta, EMD Serono of Rockland, Massachusetts, will assume full responsibility for marketing and selling the drug in the United States. Theratechnologies has retained the rights to sell the drug elsewhere in the world.

Theratechnologies submitted its NDA to the FDA on May 29, 2009. The agency filed it August 12, 2009, which initiated a substantive review of the application. The EMDAC meeting was originally scheduled for February 24, 2010, but was postponed due to administrative delays at the FDA. As a result, the FDA has indicated that the action goal date, which is the target date for the FDA to complete its review of the Egrifta NDA, will be extended to July 27 of this year.

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Previous Comments:

thuly, pietemaritzburg, 2010-05-20 12:33:54
i heard the lipo treament will available in US bt we also suffering in SA Please dont forget us i was very well structured nd pretty but now i lost all fat i only huge tummy i dnt knw what size im wearing bt my arms legs etc are thin

Jessica, , 2010-03-23 13:24:19
What I want to know is will this drugs also help with fat loss in face, and limbs?

J. Combs, Gaithersburg, MD, 2010-03-23 12:29:05
YES YES!! I hope this will work, I am so miserable with the deposits behind my stomach. I have no body fat whatsover according to my PCP and Digestive MD. And even tho' I am 6'5" tall, I weigh only 203, but I look like I am 8 months pregnant. And I know my wife would love to be able to use is, as she is 5"5" and weighs 140, with all of is below her stomach. We're both miserable like this, and we can only imagine how other are who have the fat deposits in other areas that are just uncomfortable