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Dapagliflozin (new indication: type 2 diabetes mellitus, patients ≥ 10 years)

Subject:

  • Active Substance: Dapagliflozin
  • Name: Forxiga®
  • Therapeutic area: Type 2 diabetes mellitus
  • Pharmaceutical company: AstraZeneca GmbH

Time table:

  • Start: 15.12.2021
  • Final decision by G-BA: 16.06.2022

Final decision:

  • Insulin-naive children aged 10 to 17 years with type 2 diabetes mellitus who have not achieved adequate glycemic control with their current drug therapy consisting of at least one blood glucose-lowering drug in addition to diet and exercise:
    No additional benefit proved
  • Insulin-experienced children aged 10 to 17 years with type 2 diabetes mellitus who have not achieved adequate glycemic control with their previous insulin regimen in addition to diet and exercise:
    No additional benefit proved