FDA Panel Backs Novo Diabetes Drugs, With Conditions

Law360, New York (November 9, 2012, 3:26 PM EST) -- Overcoming fears of cardiovascular risks, Novo Nordisk A/S won backing Thursday for new insulin treatments Tresiba and Ryzodeg from a U.S. Food and Drug Administration advisory panel, potentially setting the stage for a new entry into the fast-growing diabetes care market.

The Endocrinologic and Metabolic Drugs Committee split 8-4 in favor of Tresiba, which consists of a long-acting insulin analog called degludec, and Ryzodeg, which contains degludec and a quick-acting insulin analog called aspart.

The committee, which voted two days after FDA staff outlined potential heart...
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