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GALVUS/JALRA (vildagliptin),

DIABETOLOGY - New indication
Opinions on drugs - Posted on Feb 24 2015

Reason for request

extension of indication

No clinical added value demonstrated for vildagliptin combined with metformin and a sulfonylurea by comparison with triple therapy in the management of type 2 diabetes

 

  • GALVUS/JALRA has Marketing Authorisation in combination with metformin and a sulfonylurea when dual therapy with these medicines, diet and exercise do not provide adequate glycaemic control.
  • The fixed-dose combination EUCREAS/ICANDRA is indicated in combination with a sulfonylurea (i.e. triple therapy) as an adjunct to diet and exercise in adult patients inadequately controlled with metformin and a sulfonylurea.
  • 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 GALVUS/JALRA is substantial as triple oral therapy, in combination with a sulfonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.

Clinical Added Value
no clinical added value

In the absence of any direct comparison with validated and available triple therapies, the Transparency Committee considers that GALVUS/JALRA does not provide any improvement in actual benefit (level V, non-existent) in the treatment of patients with type 2 diabetes as triple oral therapy, namely, in combination with metformin and a sulfonylurea when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.

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