FDA rejects diabetes drug Bydureon

FDA rejects diabetes drug Bydureon

The U.S. Food and Drug Administration on Tuesday rejected new diabetes medication Bydureon for lack of clinical data, specifically about how the drug affects heart rate.

Bydureon makers Amylin Pharmaceuticals Inc. and Eli Lilly and Co. said that they will submit the new studies required by the FDA by the end of 2011, after which an FDA review can approve the drug by the middle part of 2012.

Shares of Amylin slid 3.4 percent in regular trading, while Shares of Lilly fell 2.5 percent at $36.50.

Bydureon is projected to have sales of more than $1 billion dollars once it gets FDA approval.

The companies said that the FDA asked for more data regarding how exenatide, the drug’s active ingredient, can impact heart muscle activity.

Amylin CEO Daniel Bradbury said that previous studies have not shown any evidence of any adverse effect of the drug on the heart.

Bydureon is a once-weekly variant of Byetta, another diabetes medication developed by Amylin and Lilly. Byetta is FDA-approved for treating type II diabetes.

The current review was submitted by the two pharmaceutical firms to the FDA in May after the FDA requested via a complete response letter additional information regarding Bydureon’s label aside from an evaluation and mitigation plan.

Amylin reported net product sales of $154 million for the third quarter, falling from $192.9 million from a year earlier.

Posted by George Daniels on Wednesday October 20 2010, 11:13 AM EST. All trademarks acknowledged. Filed under Featured News, Health. Comments and Trackbacks closed. Follow responses: RSS 2.0