Forxiga (dapagliflozin), the first-in-class diabetes medication from AstraZeneca and Bristol-Myers Squibb, has been accepted for restricted use by the Scottish Medicines Consortium (SMC), giving diabetic patients in Scotland access to a new drug therapy.
The treatment received Marketing Authorisation by the European Medicines Agency (EMA) on 14 November 2012 and has now been given the green light to be offered on the NHS to adults with type 2 diabetes in Scotland who are unable to manage their condition on metformin alone.
Under guidance issued by the SMC, physicians in Scotland can now prescribe the once-daily oral medication as dual therapy in combination with metformin, in cases where metformin alone with diet and exercise does not provide adequate blood sugar control and a sulphonylurea is inappropriate.
Dapagliflozin is the first in a new class of diabetes drugs called sodium-glucose cotransporter 2 (SGLT2) inhibitors, which work by causing more glucose to be passed out of the body via the urine, along with the associated calories. This novel mode of function helps reduce blood sugar and promote weight loss.
In clinical trials involving over 5,500 type 2 patients, the drug was shown to effectively reduce blood sugar levels and improve glycemic control. Reductions in body weight and the risk of hypoglycaemia were also reported.
But while the benefits of dapagliflozin have been documented, it’s important to note that the trials did highlight some safety concerns, such as possible liver damage and increased riss of breast and bladder cancers .
The Scottish NHS have deemed that the benefits outweigh the safety risks, but potential users should bear in mind that as the drug is new, the long term effects on humans are not yet known.
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