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Eli Lilly, Amylin and Alkermes announced that in a study designed to satisfy a request from US regulators, the type 2 diabetes drug Bydureon (extended-release exenatide) didn't affect the heart rate in healthy people. Christian Weyer, senior vice president of R&D at Amylin, noted that in the trial the GLP-1 receptor agonist "did not lead to QT prolongation, even at very high concentrations in the blood." Shares in Amylin rose as much as 10 percent on the news, while Alkermes' stock climbed as much as 6 percent.

Last year, the FDA issued a complete response letter regarding a regulatory filing for Bydureon, asking for further data on the drug's effect on heart rate. Weyer said the companies are "confident" in the new results "and will continue to work toward making Bydureon available to patients in the US as soon as possible." Eli Lilly, Amylin and Alkermes plan to include the findings in a resubmission of the Bydureon marketing application in the third quarter.

In the study, around 75 healthy people were randomised to receive either Bydureon at or above therapeutic concentrations or placebo. The companies noted that the trial met its main goal, demonstrating that Bydureon did not prolong the corrected QT interval in healthy individuals at any dose. In addition, the study found no relationship between corrected QT interval and blood levels of Bydureon. Full data from the trial will be presented at a future scientific meeting.

Bydureon was approved by regulators in Europe in June for the treatment of patients with type 2 diabetes, making it the first once-weekly treatment authorised for the condition.

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