Regulatory Focus™ > News Articles > NICE Fails to Recommend Dapagliflozin for Type 2 Diabetes

NICE Fails to Recommend Dapagliflozin for Type 2 Diabetes

Posted 01 February 2013 | By Louise Zornoza

In draft guidance published on 31 January 2013, the UK's health technologies assessment body, the National Institute of Health and Clinical Excellence (NICE), does not recommend the use of dapagliflozin (Forxiga, Bristol-Myers Squibb and Astra Zeneca) in combination therapy for the treatment of type 2 diabetes.

Dapagliflozin promotes excretion of excess glucose in the urine by blocking glucose reabsorption of in the kidneys. It is authorized in the UK for use in adults with type 2 diabetes mellitus to improve glycaemic control as either:

  1. Monotherapy when diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to intolerance; or
  2. Add-on combination therapy with other glucose-lowering agents including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control.

NICE's review was for the add-on combination therapy indication. In considering the drug's clinical effectiveness for this indication, NICE noted that the evidence was based on a combination of a short clinical trial (12 weeks) and the manufacturers' network meta-analyses, and concluded there was significant uncertainty about the validity of the results.

The agency has requested further information from the manufacturers before the second Appraisal Committee meeting in March 2013, with final guidance expected in June 2013.

Commenting on the decision, NICE Health Technology Evaluation Centre Director Professor Carole Longson said that, "Type 2 diabetes is a serious problem in the UK and it is important that there is a range of different treatment options available."

"Unfortunately, the Appraisal Committee is currently unable to recommend dapagliflozin, one of the options, for the treatment of this condition." 

A US Food and Drug Administration (FDA) advisory committee recommended against approving dapagliflozin for type 2 diabetes in July 2012, pending provision of more data on the risks and benefits of the drug.

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