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Novo Nordisk files application in Europe to include updated trial data in Tresiba label

Published 11/10/2016, 11:05 AM
Novo Nordisk files application in Europe to include updated trial data in Tresiba label
NOVOb
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  • Novo Nordisk (CO:NOVOb) (NVO -1.9%) submits a type 2 variation application to the European Medicines Agency (EMA) seeking approval to add data from two late-stage studies to the label of long-acting diabetes med Tresiba (insulin degludec injection).
  • The first, SWITCH 1, showed type 1 diabetics receiving Tresiba, in combination with insulin aspart, experienced 11% fewer hypoglycemic episodes, 36% fewer episodes of nocturnal hypoglycemia and 35% fewer episodes of severe hypoglycemia than those receiving the combination of insulin glargine and insulin aspart.
  • The second, SWITCH 2, showed type 2 diabetics treated with Tresiba plus oral antidiabetic drugs (OADs) experienced 30% fewer episodes of hypoglycemia, 42% fewer episodes of nocturnal hypoglycemia and 46% fewer episodes of severe hypoglycemia compared to insulin glargine plus OADs. The reduction in episodes of severe hypoglycemia was not statistically significant, though.
  • The studies also showed that Tresiba was non-inferior to insulin glargine as measured by HbA1c reduction.

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