Regulatory Focus™ > News Articles > NICE Gives Thumbs-Up To BMS, AstraZeneca's Forxiga for Type 2 Diabetes

NICE Gives Thumbs-Up To BMS, AstraZeneca's Forxiga for Type 2 Diabetes

Posted 27 June 2013 | By Louise Zornoza

In final guidance published 26 June 2013, the UK's National Institute for Health and Clinical Excellence (NICE) recommended dapagliflozin (Forxiga, Bristol-Myers Squibb and Astra Zeneca) for some people with type 2 diabetes.

Type 2 diabetes is a long-term condition that occurs when the body either does not produce enough insulin, or when the body's cells do not use insulin properly, resulting in elevated blood sugar levels. Prolonged, poorly controlled diabetes can, among other things, increase the likelihood of atherosclerosis, which may result in a poor blood supply to the heart, causing angina. It also increases the chance that a blood vessel in the heart or brain will become blocked, leading to a heart attack or stroke. Complications of type 2 diabetes can also lead to problems with the eyes (retinopathy), nerves (neuropathy), and kidneys (nephropathy).

Dapagliflozin is a sodium-glucose cotransporter-2 (SGLT-2) inhibitor that blocks the reabsorption of glucose in the kidneys and promotes excretion of excess glucose in the urine. The drug is recommended in combination therapy with blood-sugar-lowering drug metformin as an option for treating type 2 diabetes, if it is used as described for DPP4-inhibitors in Type 2 diabetes: the management of type 2 diabetes (NICE clinical guideline 87). The guidance also recommends dapagliflozin in combination with insulin as an option for treating type 2 diabetes. Dapagliflozin, in combination with metformin and sulfonylurea, another blood-sugar-lowering drug, is not recommended for treating type 2 diabetes, except in the context of research as part of a clinical trial.

Professor Carole Longson, Health Technology Evaluation Centre Director at NICE said: "Type 2 diabetes is a serious problem which is becoming more common in the UK. Some people with the condition need to take more than one medication to help control their blood sugar. NICE is, therefore, pleased to recommend dapagliflozin in combination therapy for some people with type 2 diabetes, which will provide another treatment option for this condition."

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