Myalepta

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metreleptin

Authorised
This medicine is authorised for use in the European Union.

Overview

An overview of Myalepta and why it is authorised in the EU

Myalepta is a medicine used in addition to diet to treat lipodystrophy, where patients have loss of fatty tissue under the skin and build-up of fat elsewhere in the body such as in the liver and muscles. The medicine is used in:

  • adults and children above the age of 2 years with generalised (throughout the body) lipodystrophy (Berardinelli-Seip syndrome and Lawrence syndrome);
  • adults and children above the age of 12 years with partial (localised) lipodystrophy (including Barraquer-Simons syndrome), when standard treatments have failed.

Myalepta contains the active substance metreleptin.

Because the number of patients with the various forms of lipodystrophy is low, the diseases are considered ‘rare’, and Myalepta was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 17 July 2012. Further information on the orphan designations can be found on the European Medicines Agency’s website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation (Bernardinelli-Seip syndrome: 17/07/12; Lawrence syndrome: 17/07/12; familial partial lipodystrophy: 17/07/12; Barraquer-Simons syndrome: 17/07/12).

This EPAR was last updated on 06/08/2018

Authorisation details

Product details
Name
Myalepta
Agency product number
EMEA/H/C/004218
Active substance
Metreleptin
International non-proprietary name (INN) or common name
metreleptin
Therapeutic area (MeSH)
Lipodystrophy, Familial Partial
Anatomical therapeutic chemical (ATC) code
A16AA
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Exceptional circumstances

This medicine was authorised under exceptional circumstances, because the applicant was unable to provide comprehensive data on the efficacy and safety of the medicine under normal conditions of use. This can happen because the condition to be treated is rare or because collection of full information is not possible or is unethical. For more information, see Pre-authorisation guidance.

Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation

Publication details
Marketing-authorisation holder
Aegerion Pharmaceuticals B.V. 
Revision
0
Date of issue of marketing authorisation valid throughout the European Union
30/07/2018
Contact address
Aegerion Pharmaceuticals B.V.
Atrium Building, 8th Floor
Strawinskylaan 3127
1077 ZX Amsterdam
The Netherlands

Product information

30/07/2018 Myalepta - EMEA/H/C/004218 -

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS

Therapeutic indication

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.

Assessment history

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