EMEA-003268-PIP01-22 - paediatric investigation plan

1-(4-(6-chloropyridazin-3-yl)piperazin-1-yl)-2-(4-cyclopropyl-3- fluorophenyl)ethan-1-one (BBP-671)

Key facts

• Active Substance:
  1-(4-(6-chloropyridazin-3-yl)piperazin-1-yl)-2-(4-cyclopropyl-3- fluorophenyl)ethan-1-one (BBP-671)
• Therapeutic area:
  Other
• Decision number:
  P/0270/2023
• PIP number:
  EMEA-003268-PIP01-22
• Pharmaceutical form(s):
  • Oral suspension
  • Tablet
• Condition(s) / indication(s):
  Treatment of Pantothenate Kinase Associated Neurodegeneration
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  BridgeBio Europe B.V.; E-mail: [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:
  14/07/2023

Decision

P/0270/2023 : EMA decision of 14 July 2023 on agreement of PIP and on granting of a deferral and a waiver for 1-(4-(6-chloropyridazin-3-yl)piperazin-1-yl)-2-(4-cyclopropyl-3- fluorophenyl)ethan-1-one (BBP-671), (EMEA-003268-PIP01-22)

Reference Number: EMA/251126/2023