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FDA: Theratechnologies Drug Cuts Abdominal Fat In HIV Patient and more patients developed diabetes and some patients in the study shifted from pre-diabetes to diabetes during treatment.
 
 
  By Jennifer Corbett Dooren
Of DOW JONES NEWSWIRES
Date: Wed, May 26, 2010 9:18 am
 
WASHINGTON (Dow Jones)--A proposed Theratechnologies Inc. (THTCF) drug cut abdominal fat in HIV patients, but might increase the risk of diabetes, a U.S. Food and Drug Administration staff review said Tuesday.
 
Theratechnologies, based in Montreal, is seeking FDA approval for a proposed drug tesamorelin to treat HIV-associated lipodystrophy, an accumulation of a specific type of fat in the abdominal region that puts patients at risk of developing cardiovascular disease.
 
Tesamorelin, which the company has proposed selling under the brand name Egrifta, faces a review on Thursday by the FDA's Endocrinologic and Metabolic Drugs Advisory Committee.
 
The committee, which is made up of non-FDA medical experts, is being asked to vote on whether it thinks the product should be approved. The product, an insulin-like shot that would be self-injected daily, is designed to help the body produce a growth hormone.
 
In briefing documents posted to the FDA's website Tuesday, agency staff reviewers said patients treated with tesamorelin had their levels of excess abdominal fat reduced by an average of 17.5%. However, the FDA said the fat mostly returned after treatment was stopped, suggesting patients would have to be treated with tesamorelin on an on-going basis.
 
Two studies were conducted that involved a total of 816 patients. During the studies 543 patients received tesamoralin while the rest received a placebo, or fake treatment for six months. At the end of the study, patients in the placebo group were then treated with tesamorelin for six months while patients previously treated with the drug were re-randomized to stay on the drug or receive a placebo shot. FDA's review said more patients developed diabetes during the study compared to patients receiving a placebo, while some patients in the study shifted from what's considered pre-diabetes to diabetes during treatment.
 
In Toronto Tuesday, shares of Theratechnologies have dropped 54% to C$2.02.
 
Canaccord Genuity analyst Neil Maruoka said the diabetes risk came as a surprise, but said questions about whether the product could reduce the risk of cardiovascular disease were expected.
 
Lipodystrophy was thought to be solely associated with anti-retroviral drugs that are used to treat HIV but there's evidence that having HIV itself plays a role.
 
Daniel Berger, an HIV specialist and founder of Northstar Healthcare in Chicago, said about 25% of HIV patients have lipodystrophy, which is marked by an accumulation of visceral fat or fat inside the body cavity. It differs from subcutaneous fat, or that type of fat that accumulates underneath the skin, and is thought to be more dangerous. Berger was one of the leaders of tesamorelin's clinical studies.
 
Theratechnogolies noted, in a document also posted to FDA's website, that there's no approved treatment for lipodystrophy and said tesamorelin has a "positive impact" on reducing visceral fat. The company also said some patients stop their anti-retroviral therapy which puts them at risk of HIV progression and other complications.
 
 
 
 
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