Forxiga (dapagliflozin), the first-in-class diabetes medication from Bristol-Myers Squibb (BMS) and AstraZenecan, has been recommended for certain patients with type 2 diabetes in England and Wales.
The National Institute for Health and Care Excellence (NICE), Britain’s healthcare cost watchdog, issued final draft guidance today supporting the once-daily drug’s use as a dual therapy in combination with insulin or metformin, and with or without other oral anti-diabetic drugs.
It adds that dapagliflozin should only be used in combination with metformin in adult patients who cannot tolerate sulphonylurea medicines or who are at significant risk of hypoglycemia.
The recommendations are based on the dapagliflozin’s novel mode of action I reducing blood glucose levels. The oral drug – the first in a new class of treatments called SGLT2 inhibitors – works independently of insulin by blocking the reabsorption of glucose by the kidneys and promoting the excretion of excess glucose from the body in the urine.
In this way, dapagliflozin removes calories from the body, which offers the added benefit of weight loss.
Dapagliflozin was granted Marketing Authorisation by the European Medicines Agency (EMA) in November 2012 and was accepted for restricted use by health regulators in Scotland in January 2013.
Following the consultation on the draft recommendations in February, NICE said the drug was not a cost-effective use of NHS resources.
But after requesting further clarification and information from the manufacturers, the Institute has now made a u-turn on its decisio, meaning type 2 diabetic patients in England and Wales now access to a new form of drug treatment .
Final NICE guidance to the NHS is expected to be published in June.

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