NICE Draft OK for Eli Lilly Diabetes Drug

The UK’s National Institute for Health and Clinical Excellence (NICE) have issued an initial recommendation of approval for the use of Eli Lilly’s Bydureon (exenatide prolonged-release suspension for injection) in triple-therapy options for people with type 2 diabetes, when control of blood glucose remains or becomes inadequate.

NICE commented that Bydureon improves glycaemic control in patients with type 2 diabetes in a number of ways.  These include: enhanced glucose-dependent insulin secretion, resulting in the release of a higher, more suitable quantity of insulin that helps lower the rise in blood sugar from eating; and reduced glucose-dependent glucagon secretion in response to eating, which helps stop the liver from overproducing sugar when it is not needed, thus avoiding hyperglycaemia.

NICE’s preliminary guidance states that Bydureon may be used, in combination with metformin and a sulphonylurea, or metformin and a thiazolidinedione, in patients if they also have:

  • a body mass index (BMI) of 35kg/m2 or higher in those of European family origin (with appropriate adjustment for other ethnic groups) and specific psychological or medical problems associated with high body weight; or
  • a BMI below 35kg/m2, for whom therapy with insulin would have significant occupational implications or weight loss would benefit other significant obesity-related comorbidities.

NICE adds that treatment with Bydureon in a triple-therapy regimen should only be continued if a beneficial metabolic response has been shown.

They also recommend the use of the drug in dual-therapy regimens (in combination with metformin or a sulphonylurea) for type 2 diabetes if:

  • either metformin or a sulphonylurea, or a treatment with metformin or a sulphonylurea, is contraindicated or not tolerated; and
  • thiazolidinediones and dipeptidyl peptidase-4 (DPP-4) inhibitors, or treatment with thiazolidinediones and DPP-4 inhibitors are contraindicated or not tolerated.

Again, treatment with Bydureon in a dual-therapy regimen should only be continued if a beneficial metabolic response has been shown, says NICE.

The director of NICE’s Health Technology Evaluation Centre, Professor Carole Longson, noted that, with type 2 diabetes becoming increasingly more common in adults, the Institute is delighted to recommend the drug as a treatment option for certain people with the condition.

Public comment on the draft recommendations are now invited until 8th November at 5pm, and it is expected that NICE will publish their final guidance in February.


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