SYNJARDY (empagliflozin, metformin) - Aged 10 years and above for the treatment of type 2 diabetes

The clinical benefit of SYNJARDY 5 mg/1,000 mg, 12.5 mg/1,000 mg (empagliflozin, metformin) film-coated tablets is substantial only “in children aged 10 years and above for the treatment of type 2 diabetes mellitus as an adjunct to diet and exercise:

• in patients insufficiently controlled on their maximally tolerated dose of metformin alone,
• in combination with insulin, in patients insufficiently controlled with metformin and insulin,
• in patients already being treated with the combination of empagliflozin and metformin as separate tablets.”

Considering:

• the absence of clinical studies conducted with the fixed-dose combination of empagliflozin and metformin (SYNJARDY),
• the clinical data available based on the results of a randomised, double-blind trial in parallel groups, conducted in 158 patients from 10 to 18 years old having demonstrated a superiority of empagliflozin all strengths 10 mg or 25 mg versus placebo, on an intermediate laboratory endpoint, HbA1c variation, with no interpretable result for each of the empagliflozin strengths,
• demonstration of the efficacy on this endpoint only as dual therapy in combination with metformin or as triple therapy with metformin and basal insulin, with an effect size that appears to be modest, as has been observed in adults,
• the absence of data on morbidity and mortality in this population of children and adolescents; however, in adults, the EMPAREG-OUTCOME study demonstrated the superiority of empagliflozin compared to placebo for the reduction of major cardiac events (death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke), and the EMPA-KIDNEY study demonstrated an efficacy of empagliflozin compared to placebo in chronic kidney disease,
• the absence of quality of life data, in this disease with a marked impact on quality of life,
• the safety profile of empagliflozin, which appears to be favourable in the paediatric and adolescent population, with limited follow-up however,

the Committee deems that SYNJARDY 5 mg/1,000 mg, 12.5 mg/1,000 mg (empagliflozin, metformin) film-coated tablets provide no clinical added value (CAV V) in the current care pathway, which includes clinically relevant comparators (see section 5.2), for children aged 10 years and above for the treatment of type 2 diabetes mellitus as an adjunct to diet and exercise, in patients insufficiently controlled on their maximally tolerated dose of metformin alone or in combination with insulin or in patients already being treated with the combination of empagliflozin and metformin as separate tablets.