EMA/PE/0000183092 - paediatric investigation plan

polypeptide consisting of a glucagon-like peptide-1 receptor agonist and an amylin receptor agonist, connected by a linker with 4 glycine residues, and connected to a C18 fatty acid side chain (NNC0487-0111)

Key facts

• Active substance:
  polypeptide consisting of a glucagon-like peptide-1 receptor agonist and an amylin receptor agonist, connected by a linker with 4 glycine residues, and connected to a C18 fatty acid side chain (NNC0487-0111)
• Therapeutic area:
  Endocrine disorders
• Decision number:
  EMA/PE/0000183092
• PIP number:
  EMA/PE/0000183092
• Pharmaceutical form(s):
  • Tablet
  • Solution for injection
• Condition(s) / indication(s):
  Treatment of obesity
• Route(s) of administration:
  • Oral use
  • Subcutaneous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  13/06/2025
• Compliance check done:
  Nu

Decision

EMA/PE/0000183092 : EMA decision of 13 June 2025 on the agreement of a paediatric investigation plan and on the granting of a deferral and a waivepolypeptide consisting of a glucagon-like peptide-1 receptor agonist...

Adopted Reference Number: EMADOC-1700519818-2192892