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The FDA says it will review clinical trial data for one of AstraZeneca's (AZN) key diabetes drugs, following concerns expressed in a medical journal last year over increased risk of heart failure.
The agency is requesting data from AZN on saxagliptin, which is marketed on its own as Onglyza or in combination with an oral hyperglycemic drug as Kombilgyze XR, for type-2 diabetes.
Diabetes drugs are one of AZN's five priority growth areas; analysts expect annual sales of the Onglyza franchise to top $1B next year and become one of the company's best-selling drugs as sales for some of its other top-sellers are forecast to decline in coming years due to generic competition.