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FDA staff: Theratech drug works, but risks weighed
 
 
  - Advisory panel to weigh Egrifta on Thursday
- FDA staff: More diabetes seen in patients given drug
- Shares fall 51 percent
 
WASHINGTON, May 25 (Reuters) - An experimental drug from Theratechnologies Inc (TH.TO) reduced abdominal fat in HIV patients, but safety concerns must be weighed, U.S. reviewers said, sending the company's shares tumbling 51 percent.
 
Food and Drug Administration staff said in documents released on Tuesday that there was an increase in diabetes among patients treated with the injectable drug, Egrifta, compared with a placebo.
 
That finding "may affect unfavorably the potential cardiovascular benefit of this therapy," the reviewers said in a preliminary analysis written for an advisory panel that will review the drug on Thursday.
 
The shares of Theratechnologies, a Canadian biotech company, were down C$2.24, or 51 percent, to C$2.13 in afternoon trading on the Toronto Stock Exchange.
 
Egrifta, known generically as tesamorelin, would be the company's first approved product if it reaches the market. Montreal-based Theratechnologies has a U.S. licensing agreement with Merck KGaA's EMD Serono division and stands to collect $215 million in milestone payments from Serono if Egrifta is approved.
 
The drug was developed to reduce fat deposits that can build up in the abdominal cavity of patients taking HIV drugs. An estimated 200,000 to 800,000 HIV patients may have the condition, known as lipodystrophy, FDA staff said. There is no approved treatment.
 
The excess fat can raise the risk of heart disease. It also may lead some patients to stop taking medications they need to keep the AIDS virus in check, as some drugs are thought to contribute to lipodystrophy.
 
With Egrifta, patients inject the drug daily into the stomach. In company studies, people treated for a year lost about 18 percent of their abdominal fat. But they gained most of it back within about three months of stopping the drug, FDA reviewers said. That means patients likely will need to use Egrifta indefinitely to maintain its benefits.
 
Reductions of cholesterol, other blood fats and waist circumference "were seen either inconsistently during the trials or were of small magnitude," FDA reviewers said.
 
The researchers measured those effects to see if the drug might lower heart disease risk.

 
The FDA said it will ask the advisory panel, a group of outside experts, to weigh the benefits versus potential risks, "especially since this treatment is anticipated to be given long-term."
 
FDA reviewers said a "considerable number" of Egrifta patients had increases in insulin-like growth factor, or IGF-1, "above the upper range of normal."
 
Theratechnologies, in a separate summary prepared for the panel, said there has been a theoretical concern high IGF-1 levels for an extended time may be associated with cancer.
The company said there was no evidence to show that higher IGF-1 levels in patients treated with Egrifta caused cancer.
 
Desjardins Securities analyst Maher Yaghi said in a research note the FDA reviewers placed a "strong emphasis on the long-term patient safety profile of the drug instead of its immediate favorable efficacy."
 
The advisory panel could recommend a post-approval study to further evaluate long-term effects or may urge a more detailed analysis of risks ahead of approval, Yaghi said.
 
The FDA usually follows panel recommendations when deciding whether to approve new drugs. A final ruling is due by July 27.
 
Theratechnologies said Egrifta offered an advance for HIV patients and potential side effects were manageable.
 
"Perhaps the benefit of greatest importance is the impact of the drug on the patient's quality of life, which is reflected in reported changes in self-image and improved relationships with other people. Patients feel more 'normal,'" the company said.
 
 
 
 
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