EMEA-003175-PIP01-21 - paediatric investigation plan

human IgG4-based bispecific antibody binding to both B-cell maturation antigen (BCMA) and cluster of differentiation 3 (CD3) (REGN5458)

Key facts

• Active substance:
  human IgG4-based bispecific antibody binding to both B-cell maturation antigen (BCMA) and cluster of differentiation 3 (CD3) (REGN5458)
• Therapeutic area:
  Oncology
• Decision number:
  P/0153/2022
• PIP number:
  EMEA-003175-PIP01-21
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of Multiple Myeloma
• Route(s) of administration:
  All routes of administration
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  13/05/2022
• Compliance check done:
  No

Decision

P/0153/2022 : EMA decision of 13 May 2022 on the granting of a product specific waiver for human IgG4-based bispecific antibody binding to both B-cell maturation antigen (BCMA) and cluster of differentiation 3 (CD3) (REGN5458) (EMEA-003175-PIP01-21)

Adopted Reference Number: EMA/205812/2022