EMEA-003024-PIP01-21 - paediatric investigation plan

2’-O-(2-methoxyethyl) modified antisense oligonucleotide targeting fused in sarcoma (FUS) pre-mRNA (ION363)

Key facts

• Active substance:
  2’-O-(2-methoxyethyl) modified antisense oligonucleotide targeting fused in sarcoma (FUS) pre-mRNA (ION363)
• Therapeutic area:
  Neurology
• Decision number:
  P/0182/2023
• PIP number:
  EMEA-003024-PIP01-21
• Pharmaceutical form(s):
  Concentrate for solution for injection
• Condition(s) / indication(s):
  Treatment of amyotrophic lateral sclerosis
• Route(s) of administration:
  Intrathecal use
• Compliance check done:
  No

Decision

P/0182/2023 : EMA decision of 15 May 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’-O-(2-methoxyethyl) modified... (EMEA-003024-PIP01-21)

Reference Number: EMA/176376/2023