Metreleptin: First Global Approval

被引：78

作者：

Chou, Ken ^{[1
]}

Perry, Caroline M. ^{[2
]}

机构：

[1] Adis R&D Insight, Auckland 0754, New Zealand

[2] Adis Int Ltd, Auckland 10, New Zealand

来源：

DRUGS | 2013年 / 73卷 / 09期

关键词：

LEPTIN-REPLACEMENT THERAPY; METHIONYL HUMAN LEPTIN; WEIGHT-LOSS; HYPOLEPTINEMIC PATIENTS; LIPODYSTROPHY; EFFICACY; PHARMACOKINETICS; OBESE; SAFETY;

D O I：

10.1007/s40265-013-0074-7

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

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.

引用

页码：989 / 997

页数：9

共 45 条

[21]

Javor ED, 2005, DIABETES, V54, pA12

[22]

JAZET I, 2013, NED TIJDSCHR GENEES, V154, pA5482

[23] Recombinant methionyl human leptin therapy in replacement doses improves insulin resistance and metabolic profile in patients with lipoatrophy and metabolic syndrome induced by the highly active antiretroviral therapy [J].

Lee, Jennifer H. ;

Chan, Jean L. ;

Sourlas, Epaminondas ;

Raptopoulos, Vassilios ;

Mantzoros, Christos S. .

JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM, 2006, 91 (07) :2605-2611

[24] Leptin replacement improves postprandial glycemia and insulin sensitivity in human immunodeficiency virus-infected lipoatrophic men treated with pioglitazone: a pilot study [J].

Magkos, Faidon ;

Brennan, Aoife ;

Sweeney, Laura ;

Kang, Eun Seok ;

Doweiko, John ;

Karchmer, Adolf W. ;

Mantzoros, Christos S. .

METABOLISM-CLINICAL AND EXPERIMENTAL, 2011, 60 (07) :1045-1049

[25]

MALLARD SP, 1997, PHARMACOL RES S, V14, P78

[26]

Mantzoros CS, 2010, ENDOCR PRACT, V16, P162

[27] Selective capacity of metreleptin administration to reconstitute CD4+ T-cell number in females with acquired hypoleptinemia [J].

Matarese, Giuseppe ;

La Rocca, Claudia ;

Moon, Hyun-Seuk ;

Huh, Joo Young ;

Brinkoetter, Mary T. ;

Chou, Sharon ;

Perna, Francesco ;

Greco, Dario ;

Kilim, Holly P. ;

Gao, Chuanyun ;

Arampatzi, Kalliope ;

Wang, Zhaoxi ;

Mantzoros, Christos S. .

PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA, 2013, 110 (09) :E818-E827

[28] Effects of exogenous leptin on satiety and satiation in patients with lipodystrophy and leptin insufficiency [J].

McDuffie, JR ;

Riggs, PA ;

Calis, KA ;

Freedman, RJ ;

Oral, EA ;

DePaoli, AM ;

Yanovski, JA .

JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM, 2004, 89 (09) :4258-4263

[29] Efficacy of Metreleptin in Obese Patients With Type 2 Diabetes: Cellular and Molecular Pathways Underlying Leptin Tolerance [J].

Moon, Hyun-Seuk ;

Matarese, Giuseppe ;

Brennan, Aoife M. ;

Chamberland, John P. ;

Liu, Xiaowen ;

Fiorenza, Christina G. ;

Mylvaganam, Geetha H. ;

Abanni, Luisa ;

Carbone, Fortunata ;

Williams, Catherine J. ;

De Paoli, Alex M. ;

Schneider, Benjamin E. ;

Mantzoros, Christos S. .

DIABETES, 2011, 60 (06) :1647-1656

[30]

*NIH, 2013, METR CLIN TRIALS

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