FDA approves new weekly injection for type 2 diabetes

The FDA (Food and Drug Administration) of the United States has approved Bydureon® pen (ex -liberation exenatidType 2.

In Spain bydureon (2 mg of exenatida once a week in injectable suspension of prolonged release) is indicated for the treatment of type 2 diabetes mellitus in combination with an oral antidiabetic (metformin, sulfonylureas, and thiazolidindione) or combinations of these (metforminand sulfonylurea or metformin and thiazolidindione) in adults who have not reached adequate glycemic control with the maximum tolerated doses of these oral treatments.

Weekly exenatida is the first and unique medication that is administered once a week for adults with type 2 diabetes. Bydureon pen is a pre -filled pen injectable from a single use that eliminates the need for the patient to transfer the medication of a vial to a vial to aSyringe for self-squeezing it.Bydureon pen contains the same formulation and the same dose as the original monodysis tray of weekly exenatida and provides the same continuous release of exenatida.

It has been shown that weekly exenatida significantly reduces HBA1C (blood glucose concentration).In an open and randomized 24 -week test, weekly exenatid) at 24 weeks (basal HBA1C values ​​of 8.5% and 8.4%, respectively).In addition, weekly exenatida produced an average reduction of the body weight of 2.3 kg, compared to a reduction of 1.4 kg with exenatida administered twice a day (baseline values ​​of 97 kg and 94 kg, respectively).Exenatida weekly is not indicated for the treatment of obesity and change in weight was a secondary assessment criterion in clinical trials.

Briggs Morrison, Executive Vice President of the Global Medicines Development Division and Medical Director of Astrazeneca declared: "We are very satisfied with the approval of Bydureon Pen, a medicine that can considerably reduce the blood concentrations of glucose and that has the beneficial effect of the potential ofWeight loss with a dosage once a week in a preloaded device.administration".

Bydureon pen released by a microspheres technology in a dosage once a week and does not require a dose degree or scaling.It can be administered at any time of the day, with or without food.

Astrazeneca plans to launch Bydureon pen in the United States this year.The monodosis of weekly exenatida will continue to be present in the US market for patients who have been prescribed weekly.

The FDA approved weekly exenatida in 2012. Weekly exenatida is currently marketed in 42 countries, including those of the European Union.

weekly exenatida should not be used for the treatment of patients with type 1 diabetes or with diabetic ketoacidosis .Weekly exenatida is not recommended as a first -line treatment for patients with insufficient glymia control with diet and exercise only.Exenatida weekly is not a substitute for insulin.The simultaneous use of weekly ex -in and insulin has not been studied and is not recommended.

about the weekly ex -in clinical development program
Exenatida approvalWeekly by the FDA was based on the safety and efficacy data obtained in the Duration-5 Pivotal clinical trial, in which the treatment with weekly exenatida improved the control of blood glucose.

The Duration-5 trial was a randomized and open clinical study conducted in 252 adult patients with type 2 diabetes and insufficient glymia control with diet and exercise only or with an oral antidiabetic treatment such as metformin, a sulfonilurea, a thiazolidine orA combination of two of these oral medications for type 2 diabetes.

In the essay, weekly exenatida was compared - with an exenatida administered twice a day- (n = 129 and n = 123, respectively).After 24 weeks of treatment, patients who received exenatted once a week presented a statistically significant average reduction of 1.6 percentage points of HBA1C (basal value of 8.5%), compared to a reduction of 0,9 percentage points (basal value of 8.4%) in patients who received an exenatida administered twice a day.HBA1C is an indicator of the average blood sugar concentration for three months.

The body weight of the patients of both treatment groups decreased at the end of the study, with an average weight loss of 2.3 kg (basal value of 97 kg) in patients treated with bydureon and 1.4 kg (basal valueof 94 kg) in the treaties with an exenatida administered twice a day (the change in the weight was a secondary assessment criterion).

The adverse event communicated more frequently in both treatment groups were nausea, but their frequency was lower in patients treated with weekly ex -in (14%) than in treaties with an exenatida administered twice a day (35%).

Other frequent adverse events appeared during the treatment in the weekly exenatida group were diarrhea (9.3% compared to 4.1%) and erythema at the place of injection (5.4% compared to 2.4%, respectively).There was no serious case of hypoglycemia in any treatment group.

Mild hypoglycemia episodes were registered in both treatment groups in patients treated with weekly 2 mg and exenatida administered twice a day 10 mcg together with a sulfonylurea (12.5% ​​compared to 11.8%, respectively).

About the agonists of the GLP-1 receptors
An agonist is a molecule, such as a drug or a hormone, which binds to a cell receiver and in doing so triggers an answer from that cell.An agonist of the 1-sized peptide receptors similar to glucagon (LPG-1) joins the GLP-1 receptors and active.These receptors produce multiple anti-hypergluzemic effects.

[IV] Over time, this sustained hyperglycemia contributes to a greater progression of the disease. [V] There are still significant non -covered medical needs, since many patients are still inadequately controlled with their current glucose reducing regime. [VI]