Memorandum

Novo Nordisk submits DEVOTE data to EMA for inclusion in Tresiba (insulin degludec) label – June 16, 2017

Yesterday, Novo Nordisk announced the submission a Type II Variation application to the EMA for the inclusion of DEVOTE cardiovascular outcomes trial (CVOT) data in the Tresiba (insulin degludec) label. Assuming a standard process, a decision on this type of submission is typically available within 60 days. The inclusion of the findings on the label would be enormously helpful getting the impressive results of the trial out to patients and providers – and in enabling Novo Nordisk to promote these results. The full DEVOTE results – which investigated the long-term impact of Tresiba compared to Sanofi’s Lantus (insulin glargine) – were presented to great fanfare this week at ADA 2017. Most notably, Tresiba produced a very significant 40% relative risk reduction for severe hypoglycemia compared to Lantus (HR=0.60, 95% CI 0.48-0.76, p<0.001 for superiority) and a whopping 53% reduced risk for nocturnal severe hypoglycemia (HR=0.47, 95% CI: 0.31-0.73, p<0.001). Impressively, these reductions in hypoglycemia occurred in the context of non-inferior A1c reductions and superior fasting plasma glucose reductions with Tresiba therapy compared to Lantus. As expected, the primary three-point MACE (non-fatal MI, non-fatal stroke, and CV death) endpoint findings of the study were reassuringly neutral, with a point estimate on the “right side” at 0.91 (95% CI:0.78-1.06, p<0.001 for non-inferiority, p=0.21 for superiority). See our initial and full coverage of the DEVOTE results for more. Previously, Novo Nordisk submitted the DEVOTE results to the FDA. In addition, the EMA has also already approved the inclusion of the SWITCH 1 and 2 data on the Tresiba label – SWITCH 1 and 2 also demonstrated impressive hypoglycemia reductions for Tresiba in a randomized, blinded, crossover manner and, notably, also assessed blood glucose-confirmed symptomatic hypoglycemia. That said, DEVOTE was a much longer and larger trial and it will be a huge plus to have data from this outcomes study in the label as well.

 

-- by Helen Gao and Kelly Close