Is Metreleptin approved by the US FDA?

Drugs@FDA lists 1 application product line for Metreleptin, including MYALEPT (Prescription).

Is Metreleptin authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Metreleptin: Myalepta.

Are there safety signals or safety updates for Metreleptin?

US FDA: 1 entry (latest 2022-02-28).

Active substance

Metreleptin

US FDA 1
EMA 1
Health Canada 3
Safety 1

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
MYALEPT	11.3MG	injectable · injection	CHIESI FARMACEUTICI SPA	Prescription	24 Feb 2014

EMA European Union — centrally authorised medicines

Myalepta Chiesi Farmaceutici S.p.A. · Authorised · authorised 30 Jul 2018 · ATC A16AA

Therapeutic indication (EMA)

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.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
MYALEPTA	02544555	3 MG / VIAL	POWDER FOR SOLUTION · SUBCUTANEOUS	CHIESI FARMACEUTICI S.P.A.
MYALEPTA	02544563	5.8 MG / VIAL	POWDER FOR SOLUTION · SUBCUTANEOUS	CHIESI FARMACEUTICI S.P.A.
MYALEPTA	02544571	11.3 MG / VIAL	POWDER FOR SOLUTION · SUBCUTANEOUS	CHIESI FARMACEUTICI S.P.A.

Safety signals and safety-related labeling changes

US FDA 28 Feb 2022 MYALEPT — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for metreleptin →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.