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ONGLYZA (saxagliptin),
DIABETOLOGY - New indication
Opinions on drugs -
Posted on
Feb 25 2015
Reason for request
extension of indication
No clinical benefit demonstrated for saxagliptin in combination with metformin and a sulfonylurea
- ONGLYZA has Marketing Authorisation in combination with metformin and a sulfonylurea when dual therapy with these medicines, diet and exercise have not provided adequate glycaemic control in adult patients with type 2 diabetes.
- The fixed-dose combination KOMBOGLYZE has Marketing Authorisation in combination with a sulfonylurea, in patients not controlled by dual therapy.
- As there are no direct comparisons with validated and available triple therapies, none can be recommended in preference to any of the others.
Clinical Benefit
| Substantial |
the actual benefit of ONGLYZA is substantial in the extension of the MA indication "In combination with metformin and a sulfonylurea when this treatment alone, combined with diet and exercise, does not provide adequate glycaemic control." |
Clinical Added Value
| no clinical added value |
In the absence of a direct comparison with validated and available triple therapies, the Transparency Committee considers that ONGLYZA does not provide an improvement in actual benefit (IAB V, non-existent) in the treatment of patients with type 2 diabetes mellitus as triple oral therapy, namely, in combination with metformin and sulfonylurea when diet and exercise plus dual therapy with these medicinal products does not provide adequate glycaemic control. |
