Eli Lilly and Co., Amylin Pharmaceuticals Inc. and Alkermes Inc. said an analysis of a 148-patient trial found no evidence that their experimental Bydureon diabetes drug causes prolonged heart rhythms.
The analysis, released in summary form Sunday at the American Diabetes Association annual scientific meeting in San Diego, found the drug “did not affect” a heart rhythm called the QT interval, according to the abstract. The analysis includes data the companies previously submitted to the U.S. Food and Drug Administration.
Last October, the FDA refused to approve Bydureon, a weekly version of Indianapolis-based Lilly and San Diego-based Amylin’s diabetes drug Byetta. The agency asked the two companies and Alkermes of Waltham, Mass., to perform a new study looking at whether high levels of Bydureon can cause an abnormal heart rhythm that may increase the risk of sudden cardiac death. The study results will be available in the second half of this year, said Christian Weyer, senior vice president at Amylin.
The results of the current analysis “are very reassuring,” Weyer said. “Ultimately, we need to await the result of the ongoing study.”
The companies plan to resubmit Bydureon for approval “very shortly” after the ongoing study is completed, he said.
European regulators gave approval to Bydureon a week ago.
In other research from the meeting, the companies reported data from a 121-patient study finding that a once-monthly version of Byetta may produce similar blood sugar control to the weekly version of Bydureon over a 20-week period.
Byetta, a twice-daily injection that has been sold since 2005, generated $710.2 million in sales last year, according to Bloomberg data.