The European Commission has approved the expanded use of Novo Nordisk’s once-daily jab Xultophy in adults with type II diabetes and moderate renal impairment.
The insulin-based combination therapy was first approved in Europe in 2014, after trials showed its ability to significantly improve glycaemic control in combination with oral glucose-lowering medicines, with reduced treatment-related side effects such as hypoglycaemia and weight gain.
According to the Danish drugmaker, in people uncontrolled on basal insulin therapy – nearly three-quarters of all type II diabetes patients – Xultophy has demonstrated a significant reduction in HbA1C of 1.9 percent with a mean weight loss of 2.7kg and a low rate of hypoglycaemia comparable to that of Tresiba.
Xultophy’s (insulin/liraglutide) expanded approval comes on the back of data from the 3,500-patient LIRA-RENAL, which demonstrated its efficacy and safety as an add-on to diabetes therapy Tresiba in patients with moderate renal impairment.
Around three million people have diabetes in the UK, already costing the NHS around £14 billion a year, but the number is expected to surge to four million by 2025.
Up to 40 percent will develop some degree of renal impairment and, according to Andrew Boulton, Professor of Medicine at the University of Manchester and Consultant Physician at Manchester Royal Infirmary, current treatment options for these patients are very limited, especially for those also living with obesity.
