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Amylin Submits Clinical and Nonclinical Sections of Rolling Biologics License Application for Metreleptin to Treat Rare Forms of Lipodystrophy
Date:12/20/2010

g extreme insulin resistance, very high triglyceride levels, difficult-to-control diabetes and hepatic steatosis (excess fat accumulation in the liver). These abnormalities result in a high risk for serious medical problems such as acute pancreatitis, accelerated atherosclerosis, vessel and nerve damage from diabetes and liver cirrhosis, which can markedly reduce quality of life and life expectancy. Because patients with lipodystrophy do not have enough fat tissue, they typically also have a deficiency of leptin, a hormone secreted by fat cells that plays a key role in regulating metabolism. Metreleptin therapy, an analog of the human hormone leptin, can substantially reduce high glucose and triglyceride levels in these patients. If approved, metreleptin would be the first therapy indicated specifically for the treatment of diabetes and high triglycerides in patients with lipodystrophy, and the first approved therapeutic use of leptin.

"We are proud to advance metreleptin to this regulatory milestone, and look forward to working with the FDA to make this important treatment more broadly available to patients with lipodystrophy," said Daniel M. Bradbury, President and Chief Executive Officer at Amylin. "The use of metreleptin to treat this rare and debilitating condition represents another example of the tremendous potential for peptide and protein science to be translated into therapies that improve the lives of patients with metabolic disorders."

About Metreleptin for Lipodystrophy

There are no therapies currently indicated specifically for the treatment of metabolic abnormalities associated with lipodystrophy. Presently, patients receive a combination of dietary modification, anti-diabetic medications and lipid-lowering agents. These traditional treatment approaches do not address the underlying cause of the metabolic abnormalities in lipodystrophy, and are often rendered marginally effective due to the severity of the condition. Data f
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SOURCE Amylin Pharmaceuticals, Inc.
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