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FDA Will Decide on Lilly's Bydureon By Jan. 28

From Associated Press (August 10, 2011)

NEW YORK -- The Food and Drug Administration plans to take until late January to make a decision on Bydureon, a once-per-week diabetes drug that has been delayed for close to a year.

The companies developing the drug, Eli Lilly & Co., Amylin Pharmaceuticals Inc. and Alkermes Inc., said regulators will return a decision on Bydureon by Jan. 28. The companies filed a new application in July, and they expected the agency to make a decision within six months.

The FDA declined to approve Bydureon in 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. The FDA is reviewing the data from those studies.

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

Amylin shares fell 7.5 percent to $9.69 Wednesday, and Alkermes stock slid 5.6 percent to $13.91. Both were unchanged in aftermarket trading. Shares of Eli Lilly declined 3.2 percent to $34.49 during the day and rose 4 cents to $34.53 after hours.


Posted: August 2011