Myalept
Myalept ingredients
| Active ingredient | Strength |
|---|---|
| Metreleptin | 11.3 mg/2.2mL |
What Myalept is used for
The FDA lists the approved uses on the official label (below). In the EU, metreleptin is approved as Myalepta for:
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.
EU wording from the European Medicines Agency; US approved uses can differ.
Key facts
- Brand
- Myalept
- Generic name
- Metreleptin
- Made by
- Chiesi USA, Inc.
- Forms
- Injection, Powder, Lyophilized, For Solution
- Given
- Subcutaneous
- Drug class
- Leptin Analog
- FDA approval
- Biologic licence (BLA) BLA125390
- On the US market since
- 2015
Official information
- Myalept prescribing information (FDA label) on DailyMed
- MedlinePlus drug information (search for Metreleptin)
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Myalept?
Myalept (Metreleptin) is a specialist medicine made by Chiesi USA, Inc., approved by the US FDA.
What are the ingredients of Myalept?
Myalept contains Metreleptin (11.3 mg/2.2mL).
Is Myalept approved in Europe?
The same active substance is approved in the EU as Myalepta.
From the FDA National Drug Code directory (open.fda.gov, public domain) and the European Medicines Agency medicines list. Page made 5 November 2026 by Satya Babu.
← All specialty medicines, USA