Novo's Proposed Insulin Drugs Could Pose Risks, FDA Says

Law360, New York (November 6, 2012, 3:41 PM EST) -- U.S. Food and Drug Administration reviewers on Tuesday raised concerns about risks of heart problems and stroke among diabetes patients using Novo Nordisk A/S' proposed insulin treatments Tresiba and Ryzodeg, potentially spelling trouble in advance of an advisory vote this week.

Studies of the potential blockbusters, seen as competitors to Sanofi SA's highly profitable insulin medicine Lantus, "raised concerns regarding the possibility of excess risk of major adverse cardiovascular events," the researchers said in a report to an independent panel that will review the drug Thursday....
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