March 24, 2017 / 11:50 AM / 4 months ago

BRIEF-Novo Nordisk gets positive opinion for label update in EU for Tresiba

2 Min Read

March 24 (Reuters) - Novo Nordisk

* The Committee for Medicinal Products for Human Use (CHMP), under the European Medicines Agency (EMA), has issued a positive opinion, recommending an update of the label for Tresiba (insulin degludec) to include data from the SWITCH 1 and 2 clinical trials

* In the trials, Tresiba, the new-generation once-daily basal insulin, demonstrated clinically relevant reductions in hypoglycaemia compared with insulin glargine U100 in people with type 1 and type 2 diabetes

* For the SWITCH 1 trial, the CHMP recommends the updated label to include results reflecting the significant reductions in hypoglycaemia

* For the SWITCH 2 trial, the CHMP recommends the updated label to include results reflecting the significant reductions in hypoglycaemia

* "An inclusion of the SWITCH trial results in the label will further support the clinical profile of Tresiba," said Mads Krogsgaard Thomsen, chief science officer

* The CHMP positive opinion is now referred for final action to the European Commission, which grants approval in the EU

* Novo Nordisk expects to receive the updated marketing authorisation in the second quarter of 2017 Source text for Eikon: Further company coverage: (Reporting by Stine Jacobsen, editing by Teis Jensen)

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