12th Feb 2014 06:49
LONDON (Alliance News) - The US Food and Drug Administration has requested clinical trial data from AstraZeneca PLC., the manufacturer of saxagliptin, to investigate a possible association between use of the type 2 diabetes drug and heart failure.
The request follows a study published in the New England Journal of Medicine, which reported an increased rate of hospitalization for heart failure, when the heart does not pump blood well enough, with use of saxagliptin compared to an inactive treatment. The study did not find increased rates of death or other major cardiovascular risks.
Saxagliptin is marketed as Onglyza and Kombiglyze XR. The drug was co-developed by the UK-based drugmaker and Bristol-Myers Squibb. AstraZeneca later acquired the diabetes joint venture.
The drug is marketed on its own as Onglyza and in combination with an oral hyperglycemic drug as Kombilgyze XR. Onglyza was approved by the regulator in 2009 and Kombiglyze in 2010.
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.
The manufacturer is expected to submit the trial data to FDA by early March, after which FDA will conduct a thorough analysis and report its findings.
The FDA added that information from the study is preliminary and that patients should not stop taking saxagliptin.
The stock closed up 1.5% on Tuesday in London at 3,974.50 pence.
Copyright RTT News/dpa-AFX
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