Eli Lilly and Company, together with Amylin Pharmaceuticals, Inc. and Alkermes, Inc., announced that the European Commission has granted marketing authorization to Bydureon (exenatide 2 mg powder and solvent for prolonged release suspension for injection).
Bydureon, a glucagon-like peptide-1 (GLP-1) receptor agonist, is the first once-weekly treatment for type 2 diabetes. It delivers glycemic control in a single weekly dose and is indicated for the treatment of type 2 diabetes in adult patients in combination with metformin, a sulfonylurea, a thiazolidinedione, metformin plus a sulfonylurea or metformin plus a thiazolidinedione.
"As the global impact of diabetes continues to expand, so does the need for innovative medicines to help people living with diabetes successfully fit treatment into their lives," said Enrique Conterno, president, Lilly Diabetes. "Bydureon is the first and only once-weekly treatment for type 2 diabetes and has demonstrated powerful efficacy in multiple clinical trials."
The EU Marketing Authorization of Bydureon is based on review of the submission package, including data from studies in the DURATION clinical programme in which exenatide resulted in improvements in glycemic control with just one dose per week. In the data submitted, Bydureon showed statistically significant improvements in glycemic control based on reduction of A1C (a measure of average blood sugar over three months) between 1.5 and 1.9 per cent after six months. Although Bydureon was not studied as a weight-loss product, most patients taking Bydureon lost weight. Further, the Bydureon submission builds upon six years of market experience with Byetta (exenatide) injection, the twice-daily form of exenatide that is available in more than 70 countries worldwide. The most common side effect with Bydureon in clinical trials was mild-to-moderate nausea, which affected approximately 20 per cent of patients and decreased over time in most patients. Other common side effects were vomiting, diarrhoea and constipation.
In the US, the New Drug Application for Bydureon (exenatide extended-release for injectable suspension) was submitted to the US Food and Drug Administration (FDA) in 2009. The FDA issued a complete response letter and requested further data in late 2010. The companies plan to submit a response in the second half of 2011. Bydureon is the proposed trade name.
Bydureon is delivered using a biodegradable microsphere technology developed by Alkermes. The medicine offers a continuous release of exenatide with just one weekly dose.
Byetta was the first glucagon-like peptide-1 (GLP-1) receptor agonist to be approved by the FDA for the treatment of type 2 diabetes. Byetta exhibits many of the same effects as the human incretin hormone GLP-1. GLP-1 improves blood sugar after food intake through multiple effects that work in concert on the stomach, liver, pancreas and brain.
Byetta is an injectable prescription medicine that may improve blood sugar (glucose) control in adults with type 2 diabetes mellitus, when used with a diet and exercise program. Byetta is not insulin and should not be taken instead of insulin. Byetta is not currently recommended to be taken with insulin. Byetta is not for people with type 1 diabetes or people with diabetic ketoacidosis. Byetta has not been studied in people who have pancreatitis.
Byetta provides sustained A1C control and low incidence of hypoglycemia when used alone or in combination with metformin or a thiazolidinedione, with potential weight loss (Byetta is not a weight-loss product). Byetta was approved in the US in April 2005 and in Europe in November 2006 and has been used by more than 1.8 million patients since its introduction.
Amylin and Lilly partnered to develop and market Bydureon, which is based on proprietary technology for long-acting medications developed by Alkermes, Inc. Bydureon was approved in the EU in June 2011 and is under regulatory review in the US.
Amylin Pharmaceuticals is a biopharmaceutical company dedicated to improving lives of patients through the discovery, development and commercialization of innovative medicines.
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations.
Alkermes, Inc. is a fully integrated biotechnology company committed to developing innovative medicines to improve patients' lives.