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FDA Approves Tesamorelin
  "The FDA recognizes the need for therapies to treat patients with HIV-lipodystrophy," said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA's Center for Drug Evaluation and Research. "The presence of excess fat with this condition may contribute to other health problems as well as affect a patient's quality of life, so treatments that demonstrate they are safe and effective at treating these symptoms are importan
Approval of Egrifta to treat lipodystrophy
On November 10, 2010, the Food and Drug Administration approved Egrifta (tesamorelin) to treat HIV patients with lipodystrophy, a condition in which excess fat develops in different areas of the body, most notably around the liver, stomach, and other abdominal organs (visceral body fat). The condition is associated with many antiretroviral drugs used to treat HIV. Egrifta was approved to induce and maintain a reduction of excess visceral abdominal fat in HIV-infected patients with lipodystrophy.
Egrifta, the first FDA-approved treatment for lipodystrophy, is a synthetic growth hormone releasing factor (GRF) drug that is administered in a once-daily injection.
The presence of excess visceral fat accumulations associated with this condition may contribute to other health problems as well as affect a patientŐs quality of life. Whether Egrifta decreases the risk of cardiovascular disease or improves compliance with antiretroviral drugs has not been studied.
Egrifta was evaluated in two clinical trials involving 816 HIV-infected adult men and women with lipodystrophy and excess abdominal fat. Of these, 543 patients received Egrifta during a 26-week, placebo-controlled period. In both studies, patients treated with Egrifta experienced greater reductions in abdominal fat (15 - 17%) as measured by CT scan, compared with patients receiving another, non-active injectable solution (placebo). Some patients reported improvements in their self image.
The most commonly reported side effects in the studies included joint pain (arthralgia), skin redness and rash at the injection site (erythema and pruritis), stomach pain, swelling, and muscle pain (myalgia). Worsening blood sugar control occurred more often in patients treated with Egrifta than with placebo.
Egrifta was developed by Montreal-based Theratechnologies Inc. and marketed in the U.S. by Rockland, Massachusetts-based EMD Serono.
Product labeling for Egrifta will be made available soon on Drugs@FDA.
press release
Nov. 11, 2010, 12:01 a.m. EST
Media Advisory & Notice of Conference Call: Theratechnologies Announces FDA's Final Decision on its New Drug Application for Tesamorelin
- Attention Business/Financial Editors and Analysts

MONTREAL, QUEBEC, Nov 11, 2010 (MARKETWIRE via COMTEX) -- Theratechnologies /quotes/comstock/11t!e:th (CA:TH 5.00, 0.00, 0.00%) advises of an upcoming conference call and webcast to discuss the final decision of the U.S. Food and Drug Administration regarding Theratechnologies' New Drug Application ("NDA"). The call will be moderated by Dr. Andrea Gilpin, Vice President, IR & Communications, at Theratechnologies. Mr. Yves Rosconi, President and CEO, Mr. Luc Tanguay, Senior Executive Vice President and Chief Financial Officer, Dr. Christian Marsolais, Vice President, Clinical Research and Medical Affairs, Dr. Martine Ortega, Vice President, Compliance and Regulatory Affairs and Mr. Pierre Perazzelli, Vice President, Pharmaceutical Development will also be participating.
The conference call will take place tomorrow, November 11, at 8:30 a.m. (Eastern Standard Time). Prior to the call, a press release will be issued at approximately 7:30 a.m.
November 11, 2010 conference call and webcast
For the conference call, interested participants are asked to dial the following numbers: 416-981-9005 or 1-800-931-6427 (toll free). Please call five minutes prior to the conference in order to ensure your participation. You can access the webcast at the following links: and
A replay of the conference call will be available from November 11, 2010 at 10:30 a.m. to November 26, 2010 at 11:59 p.m. at the following number: 416-626-4100, pass code 21488561# or 1-800-558-5253, code 21488561#. The webcast will be posted for 30 days at the following links: and
About Theratechnologies
Theratechnologies /quotes/comstock/11t!e:th (CA:TH 5.00, 0.00, 0.00%) is a Canadian biopharmaceutical company that discovers and develops innovative therapeutic products, with an emphasis on peptides, for commercialization. The Company targets unmet medical needs in specialty markets where it can retain all or part of the commercial rights to its products. Its most advanced compound, tesamorelin, is an analogue of the human growth hormone releasing factor. In 2009, Theratechnologies submitted a New Drug Application to the U.S. Food and Drug Administration ("FDA"), seeking approval of tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy. The Company's growth strategy is centered on the commercialization of tesamorelin in the United States through an agreement with EMD Serono, Inc. for HIV-associated lipodystrophy. Moreover, Theratechnologies' growth strategy will also derive from the commercialization of tesamorelin in other markets for HIV-associated lipodystrophy, as well as the development of clinical programs for tesamorelin in other medical conditions.
Theratechnologies Inc.
Andrea Gilpin
VP, IR & Communications
514-336-7800, ext. 205
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