Pharmacutical giants Amylin and Alkermes Inc. have announced that new research shows their experimental diabetes medication Bydureon is safe for the heart .
The heart-rhythm study was conducted at the request of the U.S. Food and Drug Administration (FDA), which refused to approve the product last year, saying more information was needed about its cardiac risks.
The companies have now revealed that the 75-patient study of Bydureon showed it did not interfere with the electrical activity of the heart even at high doses, a key safety measure in drug trials.
They now plan to resubmit the drug for regulatory approval in the United States with the new data in the third quarter.
Christian Weyer, senior vice president at Amylin Pharmaceuticals, said: "We are confident in these results and will continue to work toward making Bydureon available to patients in the US as soon as possible."
Bydureon is a once-weekly, longer-acting form of the companies twice-daily injection Byetta, and is part of a new wave of diabetes drugs designed to treat the rising epidemic of the disease in the US.
However, the FDA has raised safety standards for such treatments following the collapse of GlaxoSmithKline's widely-used diabetes pill Avandia, which was found to increase the risk of heart attack and stroke .
Bydureon Diabetes Treatment Passes Heart Test
Mon, 11 Jul 2011
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