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Amylin finishes BLA submission for metreleptin as treatment for conditions associated with rare forms of lipodystrophy

Tuesday, April 03 2012 | Comments
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Amylin Pharmaceuticals Inc. completed its Biologics License Application (BLA) submission to the Food and Drug Administration for the use of metreleptin to treat diabetes and/or hypertriglyceridemia in pediatric and adult patients with rare forms of lipodystrophy.

As previously reported, Amylin initiated the rolling BLA submission in December 2010 with the clinical and nonclinical sections. The firm has now submitted the chemistry, manufacturing and controls section to complete the BLA. Amylin also requested that the BLA be given priority review status.

Metreleptin has been granted an orphan drug designation and fast track status as a treatment for patients with lipodystrophy, a condition characterized by a change in the distribution of adipose tissue. Individuals with lipodystrophy lack the required fat tissue for normal metabolic function, Amylin explained, noting that there are no approved drugs to treat the underlying cause of the disease.

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