EMEA-002992-PIP01-21 - paediatric investigation plan

2-Amino-N-(4-hydroxybicyclo[2.2.2]octan-1-yl)-5-(4-((1R,5S)-3- (tetrahydro-2H-pyran-4-yl)-3-azabicyclo[3.1.0]hexan-1- yl)phenyl)nicotinamide fumarate dihydrate (INCB-00928)

Key facts

• Active Substance:
  2-Amino-N-(4-hydroxybicyclo[2.2.2]octan-1-yl)-5-(4-((1R,5S)-3- (tetrahydro-2H-pyran-4-yl)-3-azabicyclo[3.1.0]hexan-1- yl)phenyl)nicotinamide fumarate dihydrate (INCB-00928)
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0025/2022
• PIP number:
  EMEA-002992-PIP01-21
• Pharmaceutical form(s):
  • Age-appropriate oral solid dosage form
  • Film-coated tablet
• Condition(s) / indication(s):
  Treatment of fibrodysplasia ossificans progressiva
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Incyte Biosciences Distribution 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:
  31/01/2022

Decision

P/0025/2022 : EMA decision of 31 January 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-Amino-N-(4-hydroxybicyclo[2.2.2]octan...(EMEA-002992-PIP01-21)

AdoptedReference Number: EMA/11809/2022