Myalepta (metreleptin)
- Region
- 🇪🇺 EU
- Active substance
- metreleptin
- Company
- Chiesi Farmaceutici S.p.A.
- Status
- Authorised
- Therapeutic area
- Lipodystrophy, Familial Partial
- CHMP opinion
- Thu 31 May 2018
- EU approval
- Mon 30 Jul 2018
- Designations
- Orphan, Exceptional circumstances, Additional monitoring
- Application
- EMEA/H/C/004218
- ATC
- A16AA
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.