FDA ( Food and Drug Administration ) has approved Exenatide ( Byetta ), also known as synthetic exendin-4, injection as adjunctive therapy to improve blood sugar control in patients with type 2 diabetes who have not achieved adequate control on Metformin and/or a sulfonylurea.
Exenatide is the first in a new class of drugs for the treatment of type 2 diabetes called incretin mimetics and exhibits many of the same effects as the human incretin hormone glucagon-like peptide-1 (GLP-1).
GLP-1, secreted in response to food intake, has multiple effects on the stomach, liver, pancreas and brain that work in concert to regulate blood sugar.
In addition to approving Byetta for use as an adjunct to existing oral medicines, FDA also stated that Byetta is approvable as a stand-alone therapy ( monotherapy ) for patients with type 2 diabetes.
Any additional data submitted to support a monotherapy indication is expected to receive a six-month review.
Byetta is formulated for self-administration as a fixed dose, subcutaneous injection given prior to the morning and evening meals.
Byetta will be made available in both a 5-microgram per dose and a 10-microgram per dose prefilled pen-injector device.
In the three 30-week controlled trials, adverse events associated with Exenatide were generally mild to moderate in intensity.
The most frequently reported adverse event was mild-to-moderate, dose-dependent nausea.
With continued therapy in most patients who initially experienced nausea, the frequency and severity decreased over time.
Patients receiving Exenatide in combination with a sulfonylurea have an increased risk of hypoglycemia; to reduce this risk, reduction in the dose of the sulfonylurea should be considered. In the 30-week controlled clinical trials, hypoglycemia appeared to be dependent on the doses of both Exenatide and a sulfonylurea. Most episodes of hypoglycemia were mild to moderate in intensity and all were resolved with oral administration of carbohydrate.
No increased risk of hypoglycemia was observed in the 30-week controlled studies with Exenatide when used in combination with Metformin compared to placebo.
Treatment with Exenatide may result in a reduction in appetite, food intake, and/or body weight and that there is no need to modify the dosing regimen due to such effects.
Exenatide should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, nor is Exenatide a substitute for insulin in insulin-requiring patients.
Use of Exenatide is not recommended in patients with end-stage renal disease or severe renal impairment, or in patients with severe gastrointestinal disease. Exenatide should be used with caution in patients receiving oral medications that require rapid gastrointestinal absorption.
Source: Amylin & Lilly, 2005