Author: Novartis Europharm Ltd.


Long information

What is it?

Jalra is a medicine containing the active substance vildagliptin. It is available as round, pale yellow tablets (50 mg).
This medicine is the same as Galvus, which is already authorised in the European Union (EU). The company that makes Galvus has agreed that its scientific data can be used for Jalra.

Table of Contents
What is it used for?
How is it used?
How does it work?
How has it been studied?
What benefits has it shown during the studies?
What is the risk associated?
Why has it been approved?

What is it used for?

Jalra is used to treat type 2 diabetes mellitus (non-insulin-dependent diabetes). It is used together with another antidiabetes medicine (as ?dual therapy?) when the patient?s diabetes is insufficiently controlled by this other medicine taken alone. Jalra can be used with metformin, a thiazolidinedione or a sulphonylurea, but it is only used in combination with a sulphonylurea in patients who cannot take metformin.
The medicine can only be obtained with a prescription.

How is it used?

In adults, the recommended dose of Jalra is:
- one tablet in the morning and another in the evening when used with metformin or a thiazolidinedione;
- one tablet in the morning when taken with a sulphonylurea.
The daily dose should not exceed two tablets (100 mg). Jalra can be taken with or without food. Jalra is not recommended for patients who have moderate or severe problems with their kidneys, including those on haemodialysis (a blood clearance technique) with end-stage renal disease. Jalra is not recommended for patients with liver problems. It should be used with caution in patients aged over 75 years.

How does it work?

Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose (sugar) in the blood or when the body is unable to use insulin effectively. The active substance in Jalra, vildagliptin, is a dipeptidyl peptidase 4 (DPP-4) inhibitor. It works by blocking the breakdown of ?incretin? hormones in the body. These hormones are released after a meal and stimulate the pancreas to produce insulin. By increasing levels of incretin hormones in the blood, vildagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high. Vildagliptin does not work when the blood glucose is low. Vildagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon. Together, these processes reduce blood glucose levels and help to control type 2 diabetes.

How has it been studied?

The effects of Jalra were first tested in experimental models before being studied in humans. Jalra has also been studied in seven main studies involving a total of over 4,000 patients with type 2 diabetes and insufficient control of blood glucose levels.
Three of these studies looked at the effects of Jalra taken alone in a total of 2,198 patients who had not taken diabetes treatment before, comparing it to placebo (a dummy treatment), metformin or rosiglitazone (a thiazolidinedione).
The other four studies compared the effects of Jalra, taken at doses of 50 or 100 mg a day for 24 weeks, with those of placebo, when used as an add-on to existing treatment with metformin (544 patients), pioglitazone (a thiazolidinedione, 463 patients), glimepiride (a sulphonylurea, 515 patients) or insulin (296 patients). In all studies, the main measure of effectiveness was the change in blood levels of a substance called glycosylated haemoglobin (HbA1c), which gives an indication of how well blood glucose is controlled.

What benefits has it shown during the studies?

Jalra reduced levels of HbA1c in all studies. When used alone, it caused a reduction in HbA1c levels by approximately 1% from a starting level of around 8% after 24 weeks, but it was not as effective as metformin or rosiglitazone.
When used as an add-on to existing treatment for type 2 diabetes, Jalra was more effective than placebo in reducing HbA1c levels. With metformin and with pioglitazone, the 100 mg daily dose was more effective than the 50 mg daily dose, with a reduction in HbA1c levels of between 0.8 and 1.0%. In combination with glimepiride, both 50 mg and 100 mg daily doses caused a reduction of around 0.6%. In contrast, patients adding placebo to their existing treatment showed smaller changes in HbA1c levels, ranging from a fall of 0.3% to a rise of 0.2%.
Although adding Jalra to existing insulin therapy caused a greater reduction in HbA1c levels than placebo, the size of this effect was too small to be considered meaningful for patients. The company withdrew its application for the use of Jalra on its own and as an add-on to insulin during the assessment of the medicine.

What is the risk associated?

The most common side effect with Jalra (seen in 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. Its use in patients with heart disease should be limited to patients with mild disease. Because vildagliptin has been associated with liver problems, patients should have tests to check their liver before treatment with Jalra and at regular intervals during treatment.

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) concluded that Jalra?s benefits in the treatment of type 2 diabetes mellitus are greater than its risks when used as dual oral therapy in combination with metformin, a sulphonylurea or a thiazolidinedione. The Committee recommended that Jalra be given marketing authorisation.

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