|Trade names||Myalept, Myalepta, others|
|Other names||N-Methionylleptin; r-metHuLeptin, Mettreleptin (genetical recombination) (JAN JP)|
|Drug class||Leptin analog|
|Side effects||Low blood sugar, weight loss|
|Chemical and physical data|
|Molar mass||13746.46 g·mol−1|
Common side effects include low blood sugar and weight loss. Other side effects may include headache, abdominal pain, tiredness, and fever. Severe side effects may include anaphylaxis and lymphoma. It is a recombination form of leptin.
Metreleptin was approved for medical use in the United States in 2014 and Europe in 2018. In the United States it costs about 166,000 USD for a month of 11.3 mg as of 2021. This amount in the United Kingdom costs the NHS about £70,000.
In the European Union, metreleptin is indicated in addition to diet to treat lipodystrophy, where people have a loss of fatty tissue under the skin and a build-up of fat elsewhere in the body such as in the liver and muscles. It is used in adults and children above the age of two years with generalised lipodystrophy (Berardinelli-Seip syndrome and Lawrence syndrome); and in adults and children above the age of twelve years with partial lipodystrophy (including Barraquer-Simons syndrome), when standard treatments have failed.
In the United States, it is indicated as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in people with congenital or acquired generalized lipodystrophy.
It is given at an initial dose of 2.5 mg in males over 40 kg and 5 mg in females over 40 kg.
It has been approved in Japan.
Metreleptin is currently[when?] being investigated for the treatment of diabetes and/or hypertriglyceridemia, in patients with rare forms of lipodystrophy, syndromes characterized by abnormalities in adipose tissue distribution, and severe metabolic abnormalities. The FDA approved Metreleptin injection for treating complications of leptin deficiency in February 2014.[medical citation needed]
In a three-year study of metreleptin in patients with lipodystrophy organized by the National Institute of Diabetes and Digestive and Kidney Diseases at the National Institutes of Health, metreleptin treatment was associated with a significant decrease in blood glucose (A1c decreased from 9.4% at baseline to 7.0% at study end) and triglyceride concentration (from 500 mg/dl at baseline to 200 mg/dl at study end). Metreleptin is effective in most patients with generalized lipodystrophy where circulating leptin levels are extremely low. Analogous to insulin replacement for patients with type 1 Diabetes, metreleptin restores the function of a deficient hormone. However, in patients with partial lipodystrophy where there is only a relative leptin deficiency, the response to metreleptin is not universal. This may or may not be due to anti-leptin antibodies.
NHS England will commission metreleptin treatment for patients (all ages) with congenital leptin deficiency from April 1, 2019.
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