Amylin Pharma (AMLN) Completes BLA Submission to FDA for Metreleptin; Requests Priority Review
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Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) today announced that it has completed its Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) for the use of metreleptin to treat diabetes and/or hypertriglyceridemia (high levels of triglycerides in the bloodstream) in pediatric and adult patients with rare forms of lipodystrophy.
The rolling BLA submission was initiated in December 2010 with the clinical and nonclinical sections; Amylin has now submitted the chemistry, manufacturing, and controls (CMC) section to complete the BLA. Metreleptin has Fast Track designation for use in lipodystrophy patients.
Amylin also requested Priority Review, a designation given to drug candidates that offer major advances in treatment, or provide a treatment where no adequate therapy exists. The FDA typically allocates additional resources to review an application that has been designated Priority Review status under a shortened timeline.
The rolling BLA submission was initiated in December 2010 with the clinical and nonclinical sections; Amylin has now submitted the chemistry, manufacturing, and controls (CMC) section to complete the BLA. Metreleptin has Fast Track designation for use in lipodystrophy patients.
Amylin also requested Priority Review, a designation given to drug candidates that offer major advances in treatment, or provide a treatment where no adequate therapy exists. The FDA typically allocates additional resources to review an application that has been designated Priority Review status under a shortened timeline.
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