The CHMP has endorsed an update of the EU label for Novo Nordisk's Tresiba (insulin degludec) to include results from the DEVOTE trial that suggest a significant reduction in the risk of severe hypoglycaemia.
DEVOTE is a randomised, multinational and double-blinded trial conducted to confirm the cardiovascular safety of Tresiba compared to insulin glargine U100 when added to standard of care in people with type 2 diabetes.
The trial achieved its primary endpoint of demonstrating non-inferiority of major adverse cardiovascular events (MACE) with Tresiba compared to insulin glargine U100. Severe hypoglycaemia was evaluated as a secondary endpoint and 27 percent fewer patients in the Tresiba treated group experienced an episode of severe hypoglycaemia, resulting in a 40 percent overall rate reduction of total episodes of adjudicated severe hypoglycaemia. Furthermore, patients in the Tresiba treated group experienced a 53 percent relative reduction in the rate of nocturnal severe hypoglycaemia. These differences were all statistically significant.
"Our ambition is to help people with type 2 diabetes reach their treatment goals and at the same time reduce their risk of severe hypoglycaemia," said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. "With the CHMP's endorsement of the updated label for Tresiba we have passed a major milestone in insulin therapy."
In more good news for Novo Nordisk, the FDA has approved the company's Fiasp (fast-acting insulin aspart), a new fast-acting mealtime insulin, for the treatment of adults with diabetes.
Fiasp is a formulation of insulin aspart (NovoLog) developed with the aim of obtaining pharmacokinetic and pharmacodynamic properties that more closely match the natural physiological insulin mealtime response of a person without diabetes.
Novo said that in clinical trials Fiasp has demonstrated clinically relevant improvement in long-term glucose level (HbA1c). These results were achieved with a comparable overall rate of severe or blood-sugar confirmed hypoglycaemia, between Fiasp and insulin aspart.