What is Forxiga?
Forxiga is a medicine that contains the active substance dapagliflozin. It is available as tablets (5 and 10 mg).
What is Forxiga used for?
Forxiga is used to treat adults with type 2 diabetes.
Forxiga can be used on its own (alone) when diet and exercise alone do not provide adequate control of blood glucose (sugar) levels in patients who are intolerant to metformin (another diabetes medicine).
Forxiga can also be used as add-on therapy in combination with other antidiabetic medicines, including insulin, when these medicines, in combination with diet and exercise, do not provide adequate control of diabetes.
The medicine can only be obtained with a prescription.
How is Forxiga used?
The recommended dose of Forxiga is 10 mg once a day. If Forxiga is used in combination with insulin or with medicines that help the body make insulin, the dose may need to be reduced to decrease the risk of hypoglycaemia (low blood glucose). As the effects of Forxiga depend on the renal function, the effectiveness of the medicine is reduced in patients with renal insufficiency. Therefore, the use of Forxiga is not recommended in patients with moderate to severe renal impairment. A starting dose of 5 mg is recommended in patients with severe hepatic impairment.
How does Forxiga work?
Type 2 diabetes is a disease in which the pancreas does not produce enough insulin to control the level of glucose in the blood or in which the body is unable to use insulin effectively, which leads to increased levels blood glucose.
The active substance in Forxiga, dapagliflozin, works by blocking a protein in the kidneys called sodium-glucose type 2 cotransporter (SGLT2). SGLT2 is a protein responsible for the reabsorption of glucose in the bloodstream (bloodstream) from urine, when the blood is filtered into the kidneys. By blocking the action of SGLT2, Forxiga induces the elimination of more glucose through the urine and, as a result, the reduction in the concentration of glucose in the blood.
How has Forxiga been studied?
The effects of Forxiga were first tested in experimental models before being studied in humans.
Forxiga used on its own has been compared with placebo (a dummy treatment) in two studies involving 840 patients. A third study compared Forxiga with a sulphonylurea (glipizide), both given in combination with metformin in 814 patients. Four other studies compared Forxiga with placebo, as add-on therapy in combination with metformin, a sulphonylurea (glimepiride), a thiazolidinedione or insulin in 2,370 patients.
In all of the studies, the main measure of effectiveness was the level in the blood of a substance called glycosylated hemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
What benefit has Forxiga shown during the studies?
Forxiga was more effective than placebo in lowering HbA1 levels when used both alone and in combination with other antidiabetic medicines. Used alone at a dose of 10 mg, Forxiga decreased HbA1c levels by 0.66% more than placebo after 24 weeks. In combination with other antidiabetic medicines, Forxiga 10 mg decreased HbA1c levels by 0.54-0.68% more than placebo after 24 weeks.
Compared to therapy with a sulphonylurea, Forxiga has been shown to be at least as effective: both drugs resulted in a 0.52% reduction in HbA1c levels after 52 weeks.
What is the risk associated with Forxiga?
The most common side effect with Forxiga (seen in more than 1 in 10 patients) is hypoglycaemia when given in combination with a sulphonylurea or insulin. For the full list of side effects reported with Forxiga, see the package leaflet.
Forxiga must not be used in people who are hypersensitive (allergic) to dapaglifozin or any of the other ingredients.
Why has Forxiga been approved?
The CHMP concluded that Forxiga has been shown to be effective in lowering blood glucose levels in patients with type 2 diabetes, when used both alone and in combination with other antidiabetic medicines with different mechanisms of action. Also in treated patients Other beneficial effects have been observed with Forxiga including weight loss and a decrease in blood pressure.
Frequently observed side effects, such as an increase in genital and, to a lesser extent, urinary tract infections (infection of the structures that carry urine), were related to the way the medicine works and are considered manageable. . Fewer but higher numbers of bladder, breast and prostate cancers were observed in patients treated with Forxiga than in the placebo group. However, there were no differences between the groups when all tumor types were considered; furthermore, preclinical studies examining the risk of cancer development with Forxiga found no such risk. The Committee recommended further studies to investigate this issue. The CHMP concluded that Forxiga's benefits outweigh its risks and recommended that it be given a Marketing Authorization for the medicine.
More information about Forxiga
On 12 November 2012, the European Commission issued a "marketing authorization" for Forxiga, valid throughout the European Union.
For the complete version of Forxiga's EPAR, consult the Agency's website: ema.Europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about Forxiga therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 10-2012.
The information on Forxiga published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
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