MYALEPT®/ MYAPLEPTA® (METRELEPTIN)
Myalept® / Myalepta® (metreleptin) for injection is a leptin replacement therapy used with a doctor-recommended diet to treat problems caused by not having enough leptin in the body (leptin deficiency).
Lipodystrophy is a condition caused by uncontrolled loss of fat tissue. Fat cells produce a hormone, leptin, which controls appetite and the metabolism of fats and carbohydrates in the body. The loss of fat cells results in leptin deficiency which results in metabolic abnormalities including severe insulin resistance, diabetes, hypertriglyceridemia and fatty liver disease. Myalept® / Myalepta®, a leptin replacement therapy, has been shown to improve these metabolic parameters resulting in lower triglyceride levels, lower blood sugar levels and lower Hb A1C (a measure of diabetic control).
The U.S. Food & Drug Administration (FDA) granted authorisation for metreleptin under the trade name ‘Myalept’ in February 2014. Myalept® is indicated as:
An analog indicated as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy
See Myalept.com for further information (US audiences only).
The European Commission (EC) granted authorisation for metreleptin under the trade name ‘Myalepta’ in July 2018. Myalepta® is indicated as:
An adjunct to diet as a replacement therapy to treat the complications of leptin deficiency in lipodystrophy (LD) patients:
- with confirmed congenital generalised LD (Berardinelli-Seip syndrome) or acquired generalised LD (Lawrence syndrome) in adults and children 2 years of age and above
- with confirmed familial partial LD or acquired partial LD (Barraquer-Simons syndrome), in adults and children 12 years of age and above for whom standard treatments have failed to achieve adequate metabolic control.
See Myaleptainfo.eu for further information (EU audiences only)
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
Reporting forms and information can be found on the MHRA Yellow Card reporting site.
Adverse events should also be reported to Amryt Pharmaceuticals DAC on:
Tel: +44 1604 549 952 or Freephone Number +800 4447 4447