SAN DIEGO, Dec. 20, 2010 /PRNewswire-FirstCall/ — Amylin
Pharmaceuticals, Inc. (Nasdaq:
AMLN) today announced that it has submitted the initial
sections of a rolling submission for a Biologics License
Application (BLA) 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 patients with rare forms of lipodystrophy.
Consistent with the severity and rare nature of the disorder,
Amylin has received both orphan drug designation from FDA’s Office
of Orphan Products Development, as well as Fast Track designation
for the use of metreleptin in patients with lipodystrophy. The
focus of this marketing application is on rare inherited and
acquired forms of lipodystrophy.
In the first part of its rolling submission, the Company
submitted the nonclinical and clinical sections of the BLA. The
Company plans to submit the chemistry, manufacturing and controls
(CMC) section of the BLA by the end of 2011, which will complete
the submission.
“It is gratifying to see that, after years of research focused
on leptin as an effective therapy for lipodystrophy, we are now
closer to bringing this important and innovative medicine to
patients who are in dire need of better treatments,” said Phillip
Gorden, M.D., Director Emeritus, Senior Investigator, National
Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at
the National Institutes of Health (NIH). Dr. Gorden is the
principal investigator of an ongoing NIH clinical study evaluating
the long-term efficacy of metreleptin treatment in
lipodystrophy.
Lipodystrophy syndromes are characterized by abnormalities in
adipose (fat) tissue distribution with loss of subcutaneous fat,
and often manifest in childhood or adolescence. Patients with
lipodystrophy can have multiple severe metabolic abnormalities,
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