BYDUREON secures approval across the pond

Eli Lilly and Company, Amylin Pharmaceuticals, Inc. and Alkermes, Inc. have announced that BYDUREON (exenatide 2 mg powder and solvent for prolonged release suspension for injection) has received marketing authorization from the European Commission.

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INDIANAPOLIS, SAN DIEGO and WALTHAM, Mass.—Eli Lilly andCompany, Amylin Pharmaceuticals, Inc. and Alkermes, Inc. have announced thatBYDUREON (exenatide 2 mg powder and solvent for prolonged release suspension forinjection) has received marketing authorization from the European Commission.The authorization comes ahead of approval from the U.S. Food and DrugAdministration (FDA) for the drug after the FDA rejected the drug last year,asking for more clinical data.
"As the global impact of diabetes continues to expand, sodoes the need for innovative medicines to help people living with diabetessuccessfully fit treatment into their lives," said Enrique Conterno, president,Lilly Diabetes. "BYDUREON is the first and only once-weekly treatment for type2 diabetes and has demonstrated powerful efficacy in multiple clinical trials."
BYDUREON is a glucagon-like peptide-1 (GLP-1) receptoragonist, and is the first once-weekly treatment available for Type-2 diabetes.The treatment delivers glycemic control to patients and is indicated fortreating Type-2 diabetes in adult patients in combination with metformin, asulfonylurea, a thiazolidinedione, metformin plus a sulfonylurea or metforminplus a thiazolidinedione. The delivery method for BYDUREON is a biodegradablemicrosphere technology, developed by Alkermes, and the medicine provides acontinuous release of exenatide from just a single weekly dose.

GLP-1 is naturally releasedfrom cells in the gut after eating, and helps initiate the secretion andrelease of insulin from the pancreas in the presence of high blood glucose.GLP-1-based peptide drugs are artificially produced forms of GLP-1, and GLP-1receptor agonists mimic the body's process of stimulating insulin production.Using these receptor agonists can also increase satiation after eating, whichcan result in weight loss. Evidence from preclinical studies also supports theclaim that GLP-1 helps preserve the functioning of the beta cells that produceinsulin, thereby possibly helping to slow the progression of Type-2 diabetes.
BYDUREON's EU Marketing Authorization was based on thedrug's submission package, as well as data from the clinical studies in theDURATION program, which showed that exenatide produced improvements inpatients' glycemic control with just a singular weekly dose. In addition,BYDUREON displayed statistically significant improvements in glycemic controlbased on the reduction of A1C (a standard measure of a patient's average bloodsugar over three months) between 1.5 and 1.9 percent after six months. Most ofthe patients who took BYDUREON also experienced weight loss. The most commonside effect of the drug was mild to moderate nausea, which affected about 20percent of patients. Other common side effects include vomiting, diarrhea andconstipation.
BYDUREON is alonger-acting form of Byetta, which is produced by Amylin. Byetta was the firstGLP-1 receptor agonist to get FDA approval for treating Type-2 diabetes, in2005, and also secured approval in Europe in 2006.The three companies plan to resubmit BYDUREON to the FDA inthe second half of this year with the requested additional information.BYDUREON is the proposed trade name.
Diabetes affects 26 million people in the U.S. alone,according to the American Diabetes Association, and 285 million adultsworldwide, with approximately 90 to 95 percent of those affected suffering fromType-2 diabetes. According to the Centers for Disease Control and Prevention'sNational Health and Nutrition Examination Survey, about 60 percent of diabetessufferers are not achieving their target blood sugar levels with their currenttreatment program.

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