EMEA-003177-PIP01-21 - paediatric investigation plan

2'-MOE antisense oligonucleotide targeting apoC-III (ISIS 678354)

Key facts

• Active substance:
  2'-MOE antisense oligonucleotide targeting apoC-III (ISIS 678354)
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0041/2023
• PIP number:
  EMEA-003177-PIP01-21
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of familial chylomicronaemia syndrome (type I hyperlipoproteinaemia
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  31/01/2023
• Compliance check done:
  No

Decision

P/0041/2023: EMA decision of 31 January 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for 2'-MOE antisense oligonucleotide targeting apoC-III (ISIS 678354) (EMEA-003177-PIP01-21)

Adopted Reference Number: EMA/950366/2022