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dapagliflozin (Forxiga)

Advice

following a second re-submission

dapagliflozin (Forxiga®) is accepted for restricted use within NHS Scotland.

Indication under review: In adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control as add-on combination therapy in combination with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control.

SMC restriction: in triple therapy in combination with metformin and sulphonylurea, as an alternative to a dipeptidyl peptidase-4 (DPP-4) inhibitor.

SMC has previously accepted dapagliflozin for use:

  • as dual therapy in combination with metformin, when metformin alone with diet and exercise does not provide adequate glycaemic control and a sulphonylurea is inappropriate.
  • in combination with insulin, when insulin with diet and exercise, does not provide adequate glycaemic control.

Dapagliflozin is also licensed for use as monotherapy but the company’s resubmission did not relate to its use in this setting.   SMC cannot recommend  the use of dapagliflozin as monotherapy.

Drug Details

Drug Name: dapagliflozin (Forxiga)
SMC Drug ID: 799/12
Manufacturer: AstraZeneca UK Ltd
Indication: In adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control as add-on combination therapy in combination with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control.
BNF Category:
Sub Category: 6.1 Drugs used in diabetes
Submission Type: Resubmission
Status: Superseded
Date Advice Published: 7 July 2014

Archived Advice

Resubmission 10 March 2014
Full submission 14 January 2013

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