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FDA gets new report on Lilly diabetes drug

September 12, 2011

Drugmakers Eli Lilly and Co. and Amylin Pharmaceuticals Inc. said Monday that patients taking their potential once-weekly diabetes treatment, Bydureon, saw a significant improvement in cardiovascular risk factors like high blood pressure when compared to patients who received common diabetes treatments.

The companies said a new analysis of late-stage trial data submitted to the Food and Drug Administration showed patients with type 2 diabetes who received Bydureon also saw improvements in body weight and cholesterol levels.

Indianapolis-based Lilly said in a statement that diabetes patients are at least twice as likely as people without the disease to have heart disease or a stroke, and chronic conditions like obesity, high blood pressure or cholesterol increase this risk. The findings will be presented at the 47th European Association for the Study of Diabetes Annual Meeting in Lisbon, Portugal.

Lilly and Amylin, which is headquartered in San Diego, are working with Alkermes Inc. to develop the drug. The FDA plans to make a decision on whether to approve it by the end of January.

It declined to approve Bydureon last October. It asked the companies to run a thorough study that evaluated the effects of high doses of Bydureon on patients' heart rates. It also asked for data from a study that tested the effectiveness and the labeling of the safety and effectiveness, of the commercial formulation of the drug.

Bydureon contains the same ingredient as Lilly and Amylin's diabetes drug Byetta. Alkermes, of Waltham, Mass., created the technology that releases the drug over the course of a week for more convenient dosing. European Union regulators approved Bydureon in June.

Byetta, a twice-daily injection that has been sold since 2005, generated $710.2 million in sales last year.

Lilly shares fell 9 cents, to $36.04 each, in Monday trading.

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