Dapagliflozin (7) (Forxiga®) – Diabetes mellitus Type 2, ≥ 10 years

Characteristics

Start date 15.12.2021
Resolution 16.06.2022
INN Dapagliflozin
Brand name Forxiga®
Pharm. company AstraZeneca GmbH
G-BA procedure ID 2021-12-15-D-760
Therapeutic area Metabolic diseases
Reason for procedure New Indication

Indication (German)

Forxiga is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise

- as monotherapy when metformin is considered inappropriate due to intolerance

- in addition to other medicinal products for the treatment of type 2 diabetes

Subpopulation Indication Comparator
a) Insulin-naïve children and adolescents aged 10 to 17 years with diabetes mellitus (DM) type 2 who have not achieved sufficient blood glucose control with their previous drug therapy consisting of at least one blood glucose-lowering drug in addition to diet and exercise. Human insulin + Metformin
b) Insulin-experienced children and adolescents aged 10 to 17 years with diabetes mellitus (DM) type 2 who, with their previous insulin regime in addition to diet and exercise have not achieved sufficient blood glucose control Escalation of insulin therapy (conventional therapy (CT) if necessary + metformin or intensified insulin therapy (ICT)).

9. Associated procedures



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