EMA/PE/0000338563 - paediatric investigation plan

omaveloxolone

Key facts

• Invented name:
  Skyclarys
• Active substance:
  omaveloxolone
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  EMA/PE/0000338563
• PIP number:
  EMA/PE/0000338563
• Pharmaceutical form(s):
  • Capsule, hard
  • Age appropriate oral capsule formulation
• Condition(s) / indication(s):
  Treatment of Friedreich's ataxia
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  14/08/2026
• Compliance check done:
  Ei

Decision

EMA/PE/0000338563: EMA decision of 14 August 2026 on the acceptance of a modification of an agreed paediatric investigation plan for omaveloxolone (Skyclarys)

Adopted Reference Number: EMADOC-1700519818-3379396