News:Diabetes Drugs to Face Tougher Risk Scrutiny

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The FDA recently announced that it is recommending drug companies conduct clinical trials to "demonstrate that new antidiabetic therapies do not increase cardiovascular risk in comparison with existing therapies." To accomplish this task, the FDA recommends that clinical trials include more patients that are at high risk for cardiovascular events and follow these patients for up to two years. Additionally, the FDA suggests that cardiovascular events should be analyzed by an independent, blinded committee of cardiologists. The recommendation only applies to new treatments for Type 2 diabetes and will impact the ongoing approval process for saxagliptin (Bristol-Myers Squibb and AstraZeneca) and Byetta (Eli Lilly and Amylin Pharmaceuticals). (Wall Street Journal by Jennifer Corbett Dooren)