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Drugs
Published in: Drugs 9/2013

01-06-2013 | R&D Insight Report

Metreleptin: First Global Approval

Authors: Ken Chou, Caroline M. Perry

Published in: Drugs | Issue 9/2013

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Abstract

Metreleptin is an analogue of the human hormone leptin being developed by Amylin Pharmaceuticals (a subsidiary of Bristol-Myers Squibb) for the subcutaneous treatment of metabolic disorders including lipodystrophy. The compound is expected to improve insulin sensitivity, hypertriglyceridaemia and hyperglycaemia in patients with lipodystrophy who are unresponsive to conventional treatment. Metreleptin has been approved in Japan as a leptin therapy for the treatment of lipodystrophy. Amylin has also completed a submission for regulatory approval to the US FDA for metreleptin in the treatment of diabetes mellitus and/or hypertriglyceridaemia in patients with rare forms of lipodystrophy. Clinical development of the drug is also underway in the USA for the treatment of type 1 diabetes. Amgen was previously assessing the use of metreleptin as a treatment for amenorrhoea; however, it appears that development in this indication has been discontinued. This article summarizes the milestones in the development of metreleptin leading to this first approval for lipodystrophy.
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Metadata
Title
Metreleptin: First Global Approval
Authors
Ken Chou
Caroline M. Perry
Publication date
01-06-2013
Publisher
Springer International Publishing AG
Published in
Drugs / Issue 9/2013
Print ISSN: 0012-6667
Electronic ISSN: 1179-1950
DOI
https://doi.org/10.1007/s40265-013-0074-7

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