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MYALEPTA Chiesi Australia Pty Ltd
Product name
MYALEPTA
Sponsor
Accepted date
Sep-2025
Active ingredients
metreleptin
Proposed indication
Myalepta (metreleptin) is used along with diet to replace leptin in people with lipodystrophy (LD) — a rare condition where the body has little or no fat tissue, leading to serious metabolic health problems.
It is proposed to be used in:
-children (2+) and adults with generalised LD (either from birth or acquired later).
-children (12+) and adults with partial LD (inherited or acquired), only if other treatments haven’t worked to control their metabolism.
It is proposed to be used in:
-children (2+) and adults with generalised LD (either from birth or acquired later).
-children (12+) and adults with partial LD (inherited or acquired), only if other treatments haven’t worked to control their metabolism.
Application type
A (new medicine)
Publication date
Sep-2025
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.