EMEA-003239-PIP01-22 - paediatric investigation plan

Dimeric protein comprised of two disulfide-linked monomers, each being a fully human fusion protein consisting of a modified extracellular domain of the human activin receptor type IIA fused to the fragment crystallizable domain of human IgG1 Fc including the hinge region, CH2 and CH3 domains (KER-050)

Key facts

• Active substance:
  Dimeric protein comprised of two disulfide-linked monomers, each being a fully human fusion protein consisting of a modified extracellular domain of the human activin receptor type IIA fused to the fragment crystallizable domain of human IgG1 Fc including the hinge region, CH2 and CH3 domains (KER-050)
• Therapeutic area:
  • Haematology-Hemostaseology
  • Oncology
• Decision number:
  P/0407/2022
• PIP number:
  EMEA-003239-PIP01-22
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  • Treatment of myelodysplastic syndromes
  • Treatment of myelofibrosis
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  09/09/2022
• Compliance check done:
  No

Decision

P/0407/2022 : EMA decision of 9 September 2022 on the granting of a product specific waiver for dimeric protein comprised of two disulfide-linked monomers....of human IgG1 Fc including the hinge region, CH2 and CH3 domains (KER-050) (EMEA-003239-PIP01-22)

Adopted Reference Number: EMA/709250/2022