CHMP provides positive opinion for EU label update

Bagsværd, Denmark, 24 March 2017 - Novo Nordisk today announced that 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. In the trial, adults with type 1 diabetes treated with Tresiba ^® vs. insulin glargine U100, both in addition to meal-time insulin aspart, experienced statistically significant reductions in hypoglycaemia, including 11% reduction of overall symptomatic hypoglycaemia (severe or blood glucose confirmed), 36% reduction in nocturnal symptomatic hypoglycaemia and 35% reduction in severe hypoglycaemia during the trial maintenance period.

For the SWITCH 2 trial, the CHMP recommends the updated label to include results reflecting the significant reductions in hypoglycaemia. In the trial, adults with type 2 diabetes treated with Tresiba ^® vs. insulin glargine U100 experienced statistically significant reductions in hypoglycaemia, including 30% reduction in overall symptomatic hypoglycaemia (severe or blood glucose confirmed) and 42% decrease in nocturnal symptomatic hypoglycaemia, during the trial maintenance period.

"Following the submission of the application to the EMA in November 2016, we are very pleased to have received a positive opinion from the CHMP for the label update already at this point in time," said Mads Krogsgaard Thomsen, executive vice president and chief science officer at Novo Nordisk. "An inclusion of the SWITCH trial results in the label will further support the clinical profile of Tresiba ^® ".

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.

About Tresiba ^® Tresiba ^® (insulin degludec) is a once-daily basal insulin that provides duration of action beyond 42 hours with a flat and stable glucose-lowering effect. It provides low within-day variability and day-to-day variability and a lower risk of overall, nocturnal and severe hypoglycaemia vs. insulin glargine U100. On occasions when administration at the same time of day is not possible, Tresiba ^® allows for flexibility in day-to-day dosing time with a minimum of eight hours between injections. Tresiba ^® received its first regulatory approval in September 2012 and has since been approved in more than 80 countries globally. It was approved by the FDA in the United States on 26 September 2015. It is now commercially available in more than 50 countries.

About SWITCH 1 and 2 The two phase 3b, 2x32-week randomised, double-blind, crossover, treat-to-target trials were initiated to investigate the hypoglycaemia profile of Tresiba ^® compared to insulin glargine U100 in people with type 1 and type 2 diabetes, respectively. The primary endpoint was the number of severe or blood glucose confirmed symptomatic hypoglycaemic episodes observed in participants. The two secondary endpoints included: the number of severe or blood glucose confirmed nocturnal episodes experienced in participants; and the proportion of people with one or more severe hypoglycaemic episodes. In SWITCH 1, 501 people with type 1 diabetes were randomised to crossover treatment with Tresiba ^® and insulin glargine U100 in combination with insulin aspart. In SWITCH 2, 721 people with type 2 diabetes were randomised to crossover treatment with Tresiba ^® and insulin glargine U100 in combination with oral antidiabetic drugs. 

Further information

Company announcement No 21 / 2017

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