NEW YORK (AP) — Amylin Pharmaceuticals Inc. and Eli Lilly and Co. said Tuesday an analysis of prior study data showed the diabetes drug Byetta did not increase the risk of heart problems. The review comes as the Food and Drug Administration is scrutinizing safety data on developing diabetes drugs because of past issues with heart-related side effects. Under guidelines issued last year, the agency requires more tests on high-risk patients. Byetta is already on the market as a twice-daily injection, but Amylin and Eli Lilly are trying to gain approval for their new once-weekly version of the drug, exenatide LAR. It is currently under regulatory review. The companies said they intend to start a larger outcomes study to further evaluate safety. In 2007, sales of GlaxoSmithKline’s Avandia dropped after a journal report suggested it can raise chances of heart attack and heart-related death. Exenatide LAR’s likely competitor is Novo Nordisk’s liraglutide, a once-daily injection. In April, an FDA expert panel gave a split vote on whether that drug should be approved, but voted 8 to 5 that liraglutide did not appear to hasten heart problems. The panel gave Bristol-Myers Squibb Co.’s and AstraZeneca’s Onglyza, or saxagliptin, a favorable 10 to 2 recommendation, but unanimously said the drug should continue to be studied on high-risk cardiovascular patients to assure safety.
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