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This article originally posted 11 April, 2012 and appeared in  MedicationIssue 621

Amylin Seeks FDA Approval for Metreleptin

Drug maker Amylin Pharmaceuticals has filed for regulatory approval of a drug to treat diabetes and elevated triglycerides in the bloodstream in children and adults with a rare disorder.... 

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Amylin announced the submission of an application to the Food and Drug Administration for metreleptin in patients with rare forms of lipodystrophy, a life-threatening disorder estimated to affect only a few thousand people around the world.

The disease results from the body's inability to create the hormone leptin, resulting in fat buildup in the blood and organs like the liver and muscles, causing such life-threatening complications as insulin-resistant diabetes, high triglycerides in the blood -- also known as hypertriglyceridemia -- acute pancreatitis and others.

Amylin president and CEO Daniel Bradbury said, "Completion of this submission is an important milestone for Amylin and for patients with rare forms of lipodystrophy who currently have limited and often insufficient treatment options for this under-recognized and life-threatening disease." "Metreleptin is an integral component of our ongoing commitment to improve the lives of patients with metabolic diseases, from the rarest to the most prevalent."

Amylin News Release, April 4, 2012

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This article originally posted 11 April, 2012 and appeared in  MedicationIssue 621

Past five issues: Diabetes Clinical Mastery Series Issue 198 | Issue 738 | Diabetes Clinical Mastery Series Issue 197 | Issue 737 | Diabetes Clinical Mastery Series Issue 196 |

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