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EU approves Lilly's weekly diabetes drug Bydureon

June 21, 2011

European Union regulators have approved the first once-per-week diabetes medication, the companies that developed the drug said Tuesday.

Indianapolis-based Eli Lilly and Co., San Diego-based Amylin Pharmaceuticals Inc. and Alkermes Inc. said they received marketing approval for Bydureon, a drug that is intended to help patients control their blood sugar in combination with other diabetes medications. The drug is designed to increase the body's insulin production.

Bydureon is a version of Lilly and Amylin's diabetes drug Byetta, which was approved in the U.S. in April 2005 and in Europe in November 2006. Byetta, or exenatide, is taken twice a day. Alkermes, based in Waltham, Mass., created the technology that gradually releases the drug over the course of a week.

Common side effects of Bydureon included mild to moderate nausea, vomiting, diarrhea, and constipation

The companies have not received approval to sell Bydureon in the U.S. The Food and Drug Administration declined to approve Bydureon in October, asking the companies to run a thorough study that evaluated effects of bigger doses of Bydureon on patients' heart rates. The agency also requested results from a study intended to evaluate the efficacy, and labeling of the safety and effectiveness, of the commercial formulation of Bydureon.

Lilly, Amylin and Alkermes plan to submit that information in late 2011.

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