What is Jalra?
Jalra is a medicine that contains the active substance vildagliptin. It is available as light yellow round tablets (50 mg).
This medicine is identical to Galvus, already authorized in the European Union (EU). The company that makes Galvus has agreed that its scientific data will be used for Jalra.
What is Jalra used for?
Jalra is used in the treatment of type 2 diabetes mellitus (non-insulin-dependent diabetes). It is used in combination with another antidiabetic medicine (in "dual therapy"), when the patient's diabetes is not sufficiently controlled by this other medicine taken alone. Jalra can be used in combination with metformin, a thiazolidinedione or a sulphonylurea, but in patients who cannot take metformin it is only combined with a sulphonylurea.
The medicine can only be obtained with a prescription.
How is Jalra used?
In adult patients, the recommended dose of Jalra is:
- when combined with metformin or a thiazolidinedione, one tablet in the morning and one in the evening;
- if combined with a sulphonylurea, one tablet in the morning.
The daily dose of Jalra should not exceed two tablets (100 mg). Jalra can be taken with or without food.
The use of Jalra is not recommended in patients with moderate or severe kidney problems, including patients on hemodialysis (a blood clearance technique) with end-stage renal disease. The use of Jalra is not recommended in patients with liver problems. The medicine should be used with caution in patients over 75 years of age.
How does Jalra 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. The active substance in Jalra, vildagliptin, is an inhibitor of dipeptidylpeptidase 4 (DPP-4). It works by inhibiting the breakdown of 'incretin' hormones in the body. These hormones, which are released into the blood 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. Together, these processes reduce blood glucose and contribute to the control of type 2 diabetes.
What studies have been carried out on Jalra?
The effects of Jalra were first tested in experimental models before being studied in humans.
Jalra has also been tested in seven main studies involving over 4, 000 patients with type 2 diabetes and with insufficient control of blood glucose levels.
Three of these studies considered the effects of Jalra taken alone on 2 198 patients never treated for diabetes, compared with placebo (a dummy treatment), metformin or rosiglitazone (a thiazolidinedione).
The other four studies compared the effects of Jalra, at a dose of 50 or 100 mg a day for 24 weeks, with those of placebo, used in addition to the existing treatment with metformin (544 patients), pioglitazone (a thiazolidinedione, 463 patients), glimepiride (a sulphonylurea, 515 patients) or insulin (296 patients). In all the studies, the main measure of effectiveness was the change in the blood concentration of a substance called glycosylated hemoglobin (HbA1c), which gives an indication of the effectiveness of blood glucose control.
What benefit has Jalra shown during the studies?
In all studies, Jalra reduced the level of HbA1c. Used alone, the medicine resulted in a reduction in HbA1c levels of about 1% from a starting level of about 8% after 24 weeks, but was less effective than metformin or rosiglitazone.
In adjunctive therapy to existing treatment for type 2 diabetes, Jalra was more effective than placebo in reducing HbA1c levels. The daily dose of 100 mg, in combination with metformin and pioglitazone, was more effective than the 50 mg dose, resulting in a reduction in HbA1c levels of between 0.8% and 1.0%. In combination with glimepiride, both 50 and 100 mg daily doses induced a reduction of approximately 0.6%. In contrast, in patients who added placebo to existing treatment, more modest changes in the HbA1c level were observed, ranging from a decrease of 0.3% to an increase of 0.2%.
Although the addition of Jalra to existing insulin therapy resulted in a greater reduction in HbA1c levels compared to placebo, the extent of this effect was too small to be considered significant for patients.
During the evaluation of the medicine the company withdrew the authorization application for the use of Jalra alone and in addition to insulin therapy.
What is the risk associated with Jalra?
The most common side effect of Jalra (detected in a number between 1 and 10 patients in 100) is dizziness. For the full list of all side effects reported with Jalra, see the Package Leaflet.
Jalra should not be used in people who may be hypersensitive (allergic) to vildagliptin or any of the other ingredients. Use in heart disease patients should be limited to those with mild illnesses.
Because vildagliptin has been associated with liver problems, patients must have liver tests before taking Jalra and at regular intervals during treatment.
Why has Jalra been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that Jalra's benefits are greater than its risks for the treatment of type 2 diabetes mellitus when used in dual oral therapy in combination with metformin, a sulphonylurea or a thiazolidinedione. The committee recommended that Jalra be given marketing authorization.
More information on Jalra:
On 19 November 2008, the European Commission granted a marketing authorization valid for Jalra, valid throughout the European Union, to Novartis Europharm Limited.
For the full EPAR for Jalra, click here.
Last update of this summary: 10-2008.
