A once daily injection has been approved for adults with type 2 diabetes and moderate renal impairment (stage 3 chronic kidney disease) in the UK. The licence extension for Victoza is now available to almost one million people in the UK who are affected by both conditions. Currently kidney disease accounts for 11% of the cost of managing complications of type 2 diabetes to the NHS.
The decision by the European Commission (EC) provides clinicians with an effective treatment in an area where few treatments are available due to additional complications associated with chronic kidney disease. Victoza allows for the treatment of a growing number of people with both conditions by removing the need for dose adjustments while maintaining glucose control.
"Renal impairment is one of the recognised long-term complications associated with diabetes and it can be serious, debilitating or even fatal if not managed effectively", said Steve Bain, Professor of Medicine at Swansea University and Clinical Lead for the Diabetes Research Network, Wales.
He continued, "the choice of glucose-lowering therapies available to adults with both conditions is currently limited. Victoza has shown long-term blood glucose control in adults with type 2 diabetes and moderate renal impairment. The new licence extension will not only help these adults achieve glucose control, but will provide clinicians with an additional treatment option. This is paramount to the care of adults with both conditions".
Chronic kidney disease requires frequent monitoring of blood glucose levels and kidney function and if left uncontrolled may progress to renal failure, requiring dialysis or transplantation.
Diabetes treatment options are limited for people who also have chronic kidney disease because therapies may either require dose adjustments or are not recommended for use in these patients.
The licence extension for Victoza was based on efficacy and safety data from the LIRA-RENAL phase 3b clinical trial among adults with moderate renal impairment. Over 26 weeks, Victoza 1.8 mg showed superior HbA1c (blood glucose) reduction and significant weight reduction* with no worsening of renal function compared with placebo in adults receiving anti-diabetes tablets and/or insulin to control their type 2 diabetes.
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