EMEA-002845-PIP01-20 - paediatric investigation plan

Recombinant fusion protein linking iduronate 2-sulfatase to engineered Fc with binding site for transferrin receptor (DNL310)

Key facts

• Active Substance:
  Recombinant fusion protein linking iduronate 2-sulfatase to engineered Fc with binding site for transferrin receptor (DNL310)
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0429/2022
• PIP number:
  EMEA-002845-PIP01-20
• Pharmaceutical form(s):
  Powder for concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of mucopolysaccharidosis II (Hunter syndrome)
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  Denali Therapeutics Inc.

  Tel. [phone] ext 1033

  E-mail: [e-mail]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  28/10/2022

Decision

P/0429/2022: EMA decision of 28 October 2022 on the agreement of a paediatric investigation plan for recombinant fusion protein linking iduronate 2- sulfatase to engineered Fc with binding site for transferrin receptor (DNL310) (EMEA-002845-PIP01- 20)

AdoptedReference Number: EMA/826865/2022