CHMP positive opinion for Xultophy
Novo Nordisk has announced that the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has adopted a positive opinion for Xultophy, the first ever once-daily basal insulin (insulin degludec, Tresiba) and GLP-1 analogue (liraglutide, Victoza) in one pen.
The positive opinion suggests that the licence for Xultophy is just months away. The CHMP positive opinion recommends that Xultophy will be indicated for the treatment of adults with type 2 diabetes mellitus to improve glycaemic control in combination with oral glucose-lowering medicinal products when these alone or combined with basal insulin do not provide adequate glycaemic control.
Control of HbA1c is a crucial target in diabetes management. Nearly three quarters of people with type 2 diabetes on basal insulin regimens in the UK fail to reach HbA1c58mmol/mol (≤7.5%) and are therefore at a greater risk of complications. A one percentage point drop in HbA1c can lead to a 37% reduction in microvascular complications, a 14% reduction in myocardial infarctions and a 21% reduction in overall diabetes-related mortality.
“The progressive nature of type 2 diabetes often requires patients to initiate and, overtime, intensify insulin therapy to keep glucose levels under control,” said Dr Klaus Henning Jensen, medical director, UK. “Currently, to intensify their treatment,these patients have the option to increase the dose of basal insulin or add other injectables. Some patients are reluctant to step up their treatment as raising the insulin dose may in turn increase their risk of hypoglycaemia and weight gain – and most of these intensified treatments require more than one injection a day."