The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorisation for Novo Nordisk's Awiqli, a once-weekly basal insulin icodec, for treating diabetes in adult patients.
CHMP's positive opinion follows promising results from the ONWARDS Phase IIIa clinical trial programme.
Involving 4,000 adult patients with type 1 diabetes (T1D) or type 2 diabetes (T2D), the programme comprised six global Phase IIIa studies assessing the safety and efficacy of once-weekly basal insulin icodec.
The new treatment option showed superior blood sugar reduction and time in range versus daily basal insulin in individuals with T2D.
For those with T2D new to insulin therapy, the incidence of clinically significant or severe hypoglycaemia was less than one event per patient-year of exposure.
In T1D patients, once-a-week basal insulin icodec was non-inferior in lowering HbA1c [glycated haemoglobin] levels, although it presented a higher rate of severe or clinically significant hypoglycaemia versus insulin degludec [an ultralong-acting basal insulin analogue].
The overall profile of once-weekly basal insulin icodec was found to be safe and well-tolerated.
Novo Nordisk anticipates final marketing authorisation from the European Commission before the end of May 2024, marking a significant milestone for the treatment of diabetes in the European Union.
Novo Nordisk Development executive vice-president Martin Holst Lange stated: “We believe that by reducing the number of basal insulin injections from seven to one per week, Awiqlihas the potential to have a significant impact and improve treatment for people living with diabetes.
“We are committed to driving innovation in diabetes treatment, and Awiqlihas the potential to become the insulin of choice for people with type 2 diabetes initiating insulin treatment.”
The latest development comes after the US Food and Drug Administration approved the company’s Wegovy (semaglutide) as a treatment to reduce the risk of major cardiovascular events in obese or overweight adults with heart disease.
