What is Eperzan - albiglutide and what is it used for?
Eperzan is an antidiabetic medicine that contains the active substance albiglutide. It is used in adult patients with type 2 diabetes mellitus to improve the control of the level of glucose (sugar) in the blood. Eperzan can be used as sole therapy when diet and exercise alone do not provide adequate control of blood glucose levels in patients who cannot take metformin (another antidiabetic medicine). Eperzan can also be used as add-on therapy in combination with other antidiabetic medicines, including insulin, when these medicines, together with diet and exercise, do not provide adequate control of blood glucose.
How is Eperzan used - albiglutide?
Eperzan is available as a pre-filled pen containing a powder (30 and 50 mg) and a solvent to make up a solution to be injected subcutaneously. Eperzan can only be obtained with a prescription. Patients self-administer the medicine (after being properly trained) subcutaneously in the abdomen, thigh or upper arm. The recommended dose is 30 mg given once a week, but the doctor may decide to increase it to 50 mg. , depending on the effect of the medicine on blood sugar levels.
If the medicine is used in combination with a sulphonylurea or insulin, the dose of the sulphonylurea or insulin may need to be reduced to avoid hypoglycaemia (low blood glucose).
How does Eperzan - albiglutide work?
Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or where the body is unable to use insulin effectively. The active substance in Eperzan, "albiglutide, is a" GLP-1 receptor agonist. "It works by attaching to receptors for a substance called glucagon-like peptide 1 (GLP-1), which are found on the surface of cells in the pancreas. stimulating them to release insulin. After the injection of Eperzan, albiglutide reaches the receptors in the pancreas, activating them. This causes the release of insulin and helps reduce blood glucose levels and control type 2 diabetes.
What benefit has Eperzan - albiglutide shown during the studies?
The benefits of Eperzan have been studied in over 5,000 patients with type 2 diabetes in studies comparing Eperzan with placebo (a dummy treatment) or with other antidiabetic medicines, used as add-on therapy to various combinations of treatments or as a sole therapy. The main measure of effectiveness was the change in the level of glycosylated hemoglobin (HbA1c), the percentage of hemoglobin in the blood that binds to glucose. "HbA1c gives an" indication of the efficacy of blood glucose control. Eperzan was more effective than placebo in reducing HbA1c levels when used alone; it was also more effective than the antidiabetic medicines sitagliptin and glimepiride, and comparable to insulin glargine and insulin lispro when used as add-on therapy to other treatments. Two other medicines, pioglitazone and liraglutide, were more effective than Eperzan as add-on therapy. Overall, the efficacy of Eperzan in reducing HbA1c was between 0.6 and 0.9%. This is considered to be clinically significant. Data from a three-year study show that this effect was maintained over the course of long-term treatment.
What is the risk associated with Eperzan - albiglutide?
The most common side effects with Eperzan, which may affect more than 1 in 20 people, are diarrhea, nausea and injection site reactions including rash, erythema or itching. For the full list of side effects and limitations, see the package leaflet.
Why has Eperzan - albiglutide been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Eperzan's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP noted that the effectiveness of Eperzan in controlling blood glucose was clinically significant both when the medicine was used as sole therapy and compared to other medicines in therapeutic combinations. The risks observed with the medicine were similar to those of other medicines belonging to the same class, but Eperzan has the advantage of being administered only once a week.
What measures are being taken to ensure the safe and effective use of Eperzan - albiglutide?
A risk management plan has been developed to ensure that Eperzan is used as safely as possible. Based on this plan, safety information has been added to the summary of product characteristics and package leaflet for Eperzan, including the appropriate precautions to be followed by healthcare professionals and patients. Further information can be found in the summary of the risk management plan.
Other information about Eperzan - albiglutide
On 21 March 2014, the European Commission issued a "Marketing Authorization" for Eperzan, valid throughout the European Union. For the full version of the EPAR and the summary of Eperzan's risk management plans, please visit the website Agency: ema.Europa.eu/Find medicine / Human medicines / European public assessment reports. For more information on Eperzan therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist. Last update of this summary: 02-2014.
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