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

收藏

页码：989 / 997

页数：9

相关论文

共 45 条

[1] Pharmacokinetics of human leptin in mice and rhesus monkeys [J].

Ahrén, B ;

Baldwin, RM ;

Havel, PJ .

INTERNATIONAL JOURNAL OF OBESITY, 2000, 24 (12) :1579-1585

[2] Metabolic correction induced by leptin replacement treatment in young children with Berardinelli-Seip congenital lipoatrophy [J].

Beltrand, Jacques ;

Beregszaszi, Marta ;

Chevenne, Didier ;

Sebag, Guy ;

De Kerdanet, Marc ;

Huet, Frederic ;

Polak, Michel ;

Tubiana-Rufi, Nadia ;

Lacombe, Didier ;

De Paoli, Alex M. ;

Levy-Marchal, Claire .

PEDIATRICS, 2007, 120 (02) :E291-E296

[3] Leptin treatment reduces body fat but does not affect lean body mass or the myostatin-follistatin-activin axis in lean hypoleptinemic women [J].

Brinkoetter, Mary ;

Magkos, Faidon ;

Vamvini, Maria ;

Mantzoros, Christos S. .

AMERICAN JOURNAL OF PHYSIOLOGY-ENDOCRINOLOGY AND METABOLISM, 2011, 301 (01) :E99-E104

[4]

BROWN R, 2013, PED END SOC PES ANN

[5]

BROWN RJ, 2013, METRELPTIN TREATMENT

[6] Pharmacokinetics of Subcutaneous Recombinant Methionyl Human Leptin Administration in Healthy Subjects in the Fed and Fasting States Regulation by Gender and Adiposity [J].

Chan, Jean L. ;

Wong, Shekman L. ;

Mantzoros, Christos S. .

CLINICAL PHARMACOKINETICS, 2008, 47 (11) :753-764

[7] Pharmacokinetics of recombinant methionyl human leptin after subcutaneous administration: Variation of concentration-dependent parameters according to assay [J].

Chan, Jean L. ;

Wong, Shekman L. ;

Orlova, Christine ;

Raciti, Patricia ;

Mantzoros, Christos S. .

JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM, 2007, 92 (06) :2307-2311

[8] CLINICAL EFFECTS OF LONG-TERM METRELEPTIN TREATMENT IN PATIENTS WITH LIPODYSTROPHY [J].

Chan, Jean L. ;

Lutz, Karen ;

Cochran, Elaine ;

Huang, Wenying ;

Peters, Yvette ;

Weyer, Christian ;

Gorden, Phillip .

ENDOCRINE PRACTICE, 2011, 17 (06) :922-932

[9] CLINICAL CLASSIFICATION AND TREATMENT OF CONGENITAL AND ACQUIRED LIPODYSTROPHY [J].

Chan, Jean L. ;

Oral, Elif A. .

ENDOCRINE PRACTICE, 2010, 16 (02) :310-323

[10] Efficacy of leptin therapy in the different forms of human lipodystrophy [J].

Chong, A. Y. ;

Lupsa, B. C. ;

Cochran, E. K. ;

Gorden, P. .

DIABETOLOGIA, 2010, 53 (01) :27-35

← 1 2 3 4 5 →