Amylin Pharmaceuticals Inc., a biopharmaceutical company dedicated to improving lives of patients through the discovery, development and commercialization of innovative medicines, and Ireland based global biopharmaceutical company, Alkermes plc, have announced that the US Food and Drug Administration (FDA) has approved Bydureon (exenatide extended-release for injectable suspension) – the first once-weekly treatment for type 2 diabetes.
Bydureon is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes in multiple clinical settings. It will be available in pharmacies nationwide in February.
“With Bydureon, US physicians and patients can now choose a therapy that offers continuous blood sugar control in just one dose per week,” said John Buse, MD, PhD, professor of medicine, director of the Diabetes Care Centre and chief of the Division of Endocrinology at the University of North Carolina School of Medicine in Chapel Hill. “New treatment options are essential for the millions of adults with type 2 diabetes who continue to struggle to achieve optimal blood sugar control.”
The approval of Bydureon (pronounced by-DUR-ee-on) was based on safety and efficacy data from the DURATION clinical trial programme, in which treatment with Bydureon resulted in improvements in glycemic control with just one dose per week. The approval was also based on clinical experience with Byetta (exenatide) injection, a twice-daily form of exenatide that has been available in the US since June 2005 and is used in nearly 80 countries worldwide. Bydureon uses Alkermes' proprietary technology for long-acting medications to provide a controlled release of exenatide.
“As the first and only once-weekly diabetes treatment, Bydureon represents an important milestone in Amylin's promise to bring to market innovative therapies to help improve the lives of people with type 2 diabetes,” said Daniel M Bradbury, president and chief executive officer, Amylin Pharmaceuticals. “Bydureon builds upon the proven benefits of Byetta, offering significant improvements in glycemic control in a single weekly dose.”
In the DURATION-5 head-to-head clinical study, after 24 weeks of treatment, patients taking once-weekly Bydureon experienced a statistically superior reduction in A1C of 1.6 percentage points from baseline, compared to a reduction of 0.9 percentage points for patients taking Byetta. A1C is a measure of average blood sugar over three months. Both treatment groups achieved statistically significant weight loss by the end of the study, with an average loss of 5.1 pounds for patients taking Bydureon and 3.0 pounds for patients taking Byetta (weight loss was a secondary endpoint).The most frequently reported adverse event in both groups was nausea, reported less frequently by Bydureon users (14 percent) than by Byetta users (35 percent). Other common treatment-emergent adverse events in the Bydureon group included diarrhoea, upper respiratory tract infection and injection site nodules. There were no major hypoglycaemic events.
Bydureon has been approved with a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of Bydureon outweigh the risk of acute pancreatitis and the potential risk of medullary thyroid carcinoma. As part of the REMS, Amylin has established a communication plan for healthcare professionals to help minimize these risks. In addition, Amylin will fulfill a number of post-marketing requirements to further assess the impact of Bydureon on medullary thyroid cancer and cardiovascular disease.
Bydureon is provided in a straightforward single-dose tray so that patients can self-administer the once-weekly subcutaneous injection. In the DURATION clinical studies, the delivery system was well accepted by patients and physicians.
Bydureon, previously known as exenatide once weekly, is the first and only once-weekly medicine to be approved by the FDA for the treatment of type 2 diabetes. It works with the body to help make its own insulin when needed, providing continuous glycemic control with just one dose per week. Each dose of Bydureon is made up of biodegradable microspheres that provide a controlled release of exenatide throughout the week.
Bydureon is an injectable prescription medicine that may improve blood sugar (glucose) in adults with type 2 diabetes mellitus, and should be used along with diet and exercise. It is not recommended as the first medication to treat diabetes.
Bydureon is a long-acting form of the medication in Byetta (exenatide) injection so both drugs should not be used together. Bydureon is not insulin and should not be taken instead of insulin. It is not for people with type 1 diabetes or people with diabetic ketoacidosis. It is not recommended for use in children. It is not known if Bydureon is safe and effective in people with a history of pancreatitis or severe kidney problems.