What is Eperzan - albiglutide and what is it used for?
Eperzan is a diabetes medicine containing the active substance albiglutide . It is indicated in adult patients with type 2 diabetes mellitus to improve blood glucose (sugar) control. Eperzan can be used as the only 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 an adjunctive therapy in combination with other antidiabetic medicines, including insulin, when these medicines, together with diet and exercise, do not provide adequate glucose control in the blood.
How is Eperzan - albiglutide used?
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) by subcutaneous injection in the abdomen, thigh or upper arm. The recommended dose is 30 mg given once a week, but your doctor may decide to increase it to 50 mg, depending on the effects of the medicine on blood sugar levels.
If the medicine is used in combination with a sulphonylurea or insulin, it may be necessary to reduce the dose of the sulphonylurea or insulin in order to avoid hypoglycaemia (low blood glucose concentration).
How does Eperzan - albiglutide 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 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 the receptors of a substance, called the glucagon-like peptide 1 (GLP-1), which are found on the surface of pancreatic cells, stimulating them to release insulin. After Eperzan injection, 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?
Eperzan's benefits were examined in over 5, 000 patients with type 2 diabetes as part of studies comparing Eperzan with placebo (a dummy treatment) or other antidiabetic medicines used as an adjunctive therapy to various combinations of treatments or as the only 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 effectiveness of blood glucose control. Eperzan was more effective than placebo in reducing HbA1c levels when used as monotherapy; moreover, it was more effective than the antidiabetic medicines sitagliptin and glimepiride, as well as comparable to insulin glargine and insulin lispro when used as an adjunctive therapy to other treatments. Two other medicines, pioglitazone and liraglutide, were more effective than Eperzan as an adjunctive therapy. Overall, Eperzan's efficacy in reducing HbA1c was between 0.6 and 0.9%. This is considered to be clinically significant. Data from a three-year study shows that this effect was maintained during a 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 reactions at the injection site 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 Eperzan's efficacy in controlling blood glucose was clinically significant both when the medicine was used as the sole therapy and when compared to other medicines in combination 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 included in the summary of product characteristics and the package leaflet for Eperzan, including the appropriate precautions to be followed by healthcare professionals and patients. Further information is available in the summary of the risk management plan.
More information on Eperzan - albiglutide
On 21 March 2014, the European Commission issued a marketing authorization for Eperzan, valid throughout the European Union. For the full EPAR and the summary of Eperzan's risk management plans, see the Agency's website: ema.Europa.eu/Find medicine / Human medicines / European public assessment reports. For more information on Eperzan therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 02-2014.