Feb 11 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. ()
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 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.