Amylin seeks FDA approval for metreleptin

Drug used to treat rare "ultra-orphan" disorder lipodystrophy

SAN DIEGO — 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.

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.

"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," Amylin president and CEO Daniel Bradbury said. "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."

 


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