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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.

 


Actual benefit

Important

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.


Improvement in actual benefit

V (absence)

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.