EMEA-003112-PIP01-21 - paediatric investigation plan

2’-O-(2’-methoxyethyl) modified antisense oligonucleotide targeting prekallikrein mRNA (ISIS 721744)

Key facts

• Active Substance:
  2’-O-(2’-methoxyethyl) modified antisense oligonucleotide targeting prekallikrein mRNA (ISIS 721744)
• Therapeutic area:
  • Haematology-Hemostaseology
  • Pneumology-allergology
• Decision number:
  P/0274/2022
• PIP number:
  EMEA-003112-PIP01-21
• Pharmaceutical form(s):
  Concentrate for solution for injection
• Condition(s) / indication(s):
  Treatment of hereditary angioedema
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Ionis Pharmaceuticals

  Email: [e-mail]; Tel. [phone]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  10/08/2022

Decision

P/0274/2022: EMA decision of 10 August 2022 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)... (EMEA-003112-PIP01-21)