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BYDUREONâ„¢ RECEIVES MARKETING AUTHORIZATION IN EUROPE

Tue, 06/21/2011 - 3:39am
Bio-Medicine.Org

INDIANAPOLIS, SAN DIEGO and WALTHAM, Mass., June 21, 2011 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY), together with Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Alkermes, Inc. (Nasdaq: ALKS), announced today 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 program 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 percent after six months. Although BYDUREON was not studied as a weight-loss product, most patients taking BYDUREON lost weight. Further, the BYDUREON s

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