FDA’s tougher guidelines on diabetic drugs to avoid potential cardiac risks

In response to the increasing heart attack risks, the FDA has revised its guidelines for diabetes drug. The agency has called for more scrutiny on heart condition risks.

The concern was raised two years ago, over potential heart risks for patients taking GlaxoSmithKline’s diabetes drug Avandia. Both the American Diabetes Association and its European counterpart have removed the drug from their recommended treatments, and consumer group Public Citizen is urging U.S. regulators to ban the drug. Both the American Diabetes Association and its European counterpart have removed the drug from their recommended treatments, and consumer group Public Citizen is urging U.S. regulators to ban the drug.

San Diego-based Amylin Pharmaceuticals Inc. is in the midst of wrapping up development of exenatide LAR, the once-weekly version of its twice-daily diabetes drug Byetta. Meanwhile, Denmark-based Novo Nordisk, is developing the once-daily drug liraglutide.Still, Amylin has not received FDA approval yet to include data from a combined Byetta/LAR patient database of 3,000 people for an application seeking approval, said Citi analyst Dr. Yaron Werber, in a note to investors.

Byetta, which is made in a partnership with Indianapolis-based Eli Lilly & Co. and Cambridge, Mass.-based Alkermes Inc., has had its ups and downs over the past year. Analysts have considered sales lackluster for several quarters now with Amylin reporting a wider third-quarter loss on higher costs for an expanding sales force and drug development.

Source: AP

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