What is Icandra?
Icandra is a medicine containing the active substances vildagliptin and metformin hydrochloride. It is available as oval tablets (light yellow: 50 mg of vildagliptin and 850 mg of metformin hydrochloride; dark yellow: 50 mg of vildagliptin and 1 000 mg of metformin hydrochloride).
This medicine is identical to Eucreas, already authorized in the European Union (EU). The manufacturer of Eucreas has agreed that its scientific data will be used for Icandra.
What is Icandra used for?
Icandra is used to treat type 2 diabetes (non-insulin-dependent diabetes). It is used in patients whose disease is not sufficiently controlled with the maximum tolerated dose of metformin taken alone or who are already taking the combination of vildagliptin and metformin as separate tablets.
The medicine can only be obtained with a prescription.
How is Icandra used?
The recommended dose of Icandra is one tablet twice a day, one tablet in the morning and one in the evening. The choice of the initial dose depends on the dose of metformin currently taken by the patient, but the recommended dose is 50 mg of vildagliptin and 1 000 mg of metformin twice a day. Patients already taking vildagliptin and metformin should switch to Icandra tablets containing the same doses of each active ingredient. Doses of vildagliptin greater than 100 mg are not recommended. Taking Icandra during or immediately after meals may reduce stomach problems caused by metformin.
Icandra should not be used by patients with moderate or severe kidney problems or liver disorders. Renal function should be monitored regularly in elderly patients taking Icandra. We do not recommend the use of Icandra in patients over 75 years of age.
How does Icandra work?
Type 2 diabetes is a disease in which the pancreas does not produce enough insulin to control the level of glucose (sugar) in the blood or where the body is unable to use insulin effectively. Icandra contains two active ingredients, each with a different mechanism of action. Vildagliptin, a dipeptidyl-peptidase 4 (DPP-4) inhibitor, works by inhibiting the degradation of "incretin" hormones in the body. These hormones, which are released after a meal, stimulate the pancreas to produce insulin. By increasing the level of incretin in the blood, vildagliptin stimulates the pancreas to produce more insulin when the glycemic rate is high. Vildagliptin does not work if blood glucose concentration is low. Vildagliptin also reduces the amount of glucose produced by the liver by increasing insulin levels and reducing the levels of the glucagon hormone. Metformin basically inhibits glucose production and reduces its absorption in the intestine. The result of the combined action of the two active ingredients consists in a reduction of the glucose present in the blood, which helps to control type 2 diabetes.
How has Icandra been studied?
Vildagliptin as a monotherapy was approved by the European Union in September 2007 under the name Galvus, while metformin has been available in the EU since 1959. Vildagliptin can be used with metformin in patients with type 2 diabetes, whose disease is not sufficiently controlled with metformin alone. Studies carried out on Galvus in addition to the
metformin have been used to support the use of Icandra for the same indication. In these studies the concentration in the blood of a substance called glycosylated hemoglobin (HbA1c) was measured, which gives an indication of the effectiveness of blood glucose control.
The applicant also presented the results of two studies showing that the active ingredients in the two dosages of Icandra were absorbed by the body in the same way as when they were taken in separate tablets.
What benefit has Icandra shown during the studies?
Vildagliptin was more effective than placebo (a dummy treatment) in reducing HbA1c levels when added to metformin. Patients who added vildagliptin reported a decrease in HbA1c levels of 0.88% after 24 weeks, with an initial level of 8.38%. Instead, the patients who added the placebo recorded smaller changes in HbA1c levels, with an increase of 0.23%, starting from an initial level of 8.30%.
What is the risk associated with Icandra?
The most common side effects with Icandra (seen in more than 1 patient in 10) are nausea, vomiting, diarrhea, abdominal pain and loss of appetite. For the full list of all side effects reported with Icandra, see the Package Leaflet.
Icandra should not be used in people who may be hypersensitive (allergic) to vildagliptin, metformin or any of the other ingredients. It must not be used in patients who present with diabetic ketoacidosis (high levels of ketones and acids in the blood), diabetic precoma, kidney or liver problems, conditions that may affect the kidneys or diseases that cause a reduction in the oxygen supply to the tissues such as heart or lung failure or a recent heart attack. Furthermore, it should not be used in patients with alcohol intoxication (excessive alcohol consumption) or alcoholism, nor during breastfeeding. For the full list of usage restrictions, see the package leaflet.
Why has Icandra been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that vildagliptin taken with metformin reduces blood glucose levels and that the combination of the two active ingredients in one tablet can help patients to stick to the treatment. The Committee therefore decided that Icandra's benefits are greater than its risks in the treatment of patients with type 2 diabetes mellitus, who cannot achieve sufficient glycemic control at their maximum tolerated dose of oral metformin alone or who are already in therapy with the combination of vildagliptin and metformin as separate tablets. The Committee recommended that Icandra be given marketing authorization.
More information on Icandra
On 1 December 2008, the European Commission issued a marketing authorization to Novartis Europharm Limited for Vildagliptin / Metformin Hydrochloride Novartis, valid throughout the European Union. On 6 February 2009 the name of the medicine was changed to Icandra.
For the full EPAR of Icandra, click here.
Last update of this summary: 02-2009.
