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Update on Timeline for FDA Action Date for Theratechnologies' Tesamorelin New Drug Application - press release
  July 20, 2010, 9:10 a.m. EDT
note from Jules: at the hearing the sentiment by the FDA Advisory Comm was very strong to approve as you can see immediately below with a 16-0 vote to recommend approval. There were several community testimonies at the open public part of the meeting which I think appeared to provide impetus to the committee to approve, So what's holding it up? I don't know, we can only speculate. Below are links to a number of reports I provided from the hearing including the full FDA review docum ent. The potential adverse events such as potential for increased glucose abnormalities or diabetes, which the committee felt is manageable, and the lack of evidence of beneficial CVD outcomes did not deter the committee from strongly endorsing approval because of the negative effects of belly fat accumulation associated with lipodystrophy, citing that the "the risk-benefit approval for the treatment of excess abdominal fat in HIV+ individuals with lipodystrophy".
VOTE: 16-0 to recommend approval for tesamorelin - 'benefit ...
During the panel discussion on the question about concern regarding the diabetes and glucose trends in the studies associated with tesamorelin. ...
MONTREAL, CANADA, Jul 20, 2010 (MARKETWIRE via COMTEX) -- Theratechnologies announced today that it has received feedback from the U.S. Food and Drug Administration ("FDA" or the "Agency") regarding the timeline to review tesamorelin's New Drug Application for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy. The FDA has indicated that the review is progressing well. The Company now expects to have an official response in the fourth quarter of 2010 (from Jules: it appears that an announcement of approval could have been forthcoming by now so perhaps this is a delay by the FDA). Theratechnologies and the Agency continue the positive and constructive dialogue regarding the regulatory process for tesamorelin.
About HIV-Associated Lipodystrophy
Several factors including a patient's antiretroviral drug regimen and the HIV virus itself are thought to contribute to HIV-associated lipodystrophy, which is characterized by body composition changes, dyslipidemia and glucose intolerance. The changes in body composition include excess abdominal fat accumulation. There is currently no approved treatment available for the excess abdominal fat in HIV-infected patients with lipodystrophy.
About Theratechnologies
Theratechnologies /quotes/comstock/11t!th 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 financially attractive 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, 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 and in other markets for HIV-associated lipodystrophy, as well as the development of clinical programs for tesamorelin in other medical c onditions.
Forward-Looking Information
This press release contains certain statements that are considered "forward-looking information" within the meaning of applicable securities legislation. This forward-looking information includes, but is not limited to, information regarding approval of tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy by the FDA and the timeline by which a response will be provided by the FDA to the Company regarding its New Drug Application. Forward-looking information is based upon a number of assumptions and is subject to a number of risks and uncertainties, many of which are beyond the Company's control that could cause actual results to differ materially from those that are disclosed in or implied by such forward-looking information. These risks and uncertainties include the risk that the FDA does not approve tesamorelin for the treatment of excess abdominal fat in HIV-infe cted patients with lipodystrophy or that the timeline regarding an official response be delayed. Certain assumptions made in preparing the forward-looking information include, among others, that the Company and the FDA will review on a timely basis the exchange of information between each of them, that the discussions will remain positive and that the FDA will approve tesamorelin. All of the forward-looking information is qualified by the foregoing cautionary statements, and there can be no guarantee that the results or developments anticipated by the Company will be realized. Forward-looking information reflects current expectations regarding future events only as of the date of release of this press release. Investors are referred to the Company's public filings available at In particular, further details on these risks and descriptions of these risks are disclosed in the "Risk and Uncertainties" section of the Company's Annual Information Form, dated Februa ry 23, 2010, for the year ended November 30, 2009.
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< div class="s" style="max-width: 42em; ">In summary, treatment with a fixed tesamorelin daily regimen of 2 mg had the following effect on serum IGF-1 levels: (see full FDA discussion from their ...
Tesamorelin FDA Briefing Document pdf attached
There were no clinically meaningful changes in mean values for fasting blood glucose, fasting insulin, HOMA-IR and HbA1c at Week 26 between tesamorelin- and ...
Effects of Tesamorelin, a Growth Hormone-Releasing Factor, in HIV ...
Jan 23, 2010 ... "In contrast to a prior study of tesamorelin, the current study did not show a significant decrease in triglycerides, but rather a trend, ...
Theratechnologies Inc.
Andrea Gilpin
Vice President, IR & Communications
514-336-7800 x 205
SOURCE: Theratechnologies inc.
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