EU may expand Tresiba indication

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The EU's Committee for Medicinal Products for Human Use is endorsing expanded indications for Novo Nordisk's Type 2 diabetes medications Tresiba and Victoza.

The company said in a statement that if the European Medicines Agency agrees, new labels will indicate that the long-acting basal insulin Tresiba can be prescribed in tandem with a GLP-1 like Victoza, and that Victoza can be prescribed along with a long-acting basal insulin.

The potential expansion comes soon after the FDA put Tresiba at arm's-length in February, when it told the drugmaker to run cardiovascular safety tests before it would consider an approval.

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