FDA to review possible heart risks with AstraZeneca's diabetes drug

February 11, 2014 | Esha Dey

(Reuters) - The U.S. Food and Drug Administration said it will review possible heart risks associated with AstraZeneca Plc's widely-used diabetes drug saxagliptin, marketed as Onglyza and Kombiglyze XR.

The health regulator said it requested for data from clinical trials after the New England Journal of Medicine published data that showed a small rise in hospitalizations for heart failure among patients using saxagliptin. (link.reuters.com/ven76v)

The data was published by NEJM in September and was based on a study supported by AstraZeneca and Bristol-Myers Squibb Co, with whom AstraZeneca co-developed the drug before buying all rights in a deal completed earlier this month.

That study did not find an increase in the rate of deaths or other major cardiovascular risks, including heart attacks or strokes, in patients who received saxagliptin, the FDA said on its website on Tuesday.

The FDA said it asked for the trial data to be submitted by early March, after which it would analyze and publicly report the findings.

The FDA said it considers the information in the NEJM study to be preliminary and that healthcare professionals should continue to prescribe the drug according to the recommendation on the drug's label.

AstraZeneca's shares were up 0.8 percent at $64.93 in morning trading on the New York Stock Exchange.

The review of the saxagliptin trial data was part of a broader evaluation of all type 2 diabetes drugs and cardiovascular risk, the FDA said.

Heart-related problems, such as ones seen with GlaxoSmithKline's Avandia pill, are a concern with diabetes drugs, especially as diabetics also have an increased risk of heart troubles.

Saxagliptin is used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. It works by increasing the amount of insulin produced by the body after meals, when blood sugar is high.

Type 2 diabetes is a disease in which there is a high level of sugar in the blood as the body does not make or properly use the insulin hormone.


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