The positive CHMP opinion is based on results from the ONWARDS phase 3a clinical trial programme
Awiqli recommended for approval for the treatment of diabetes by the European regulatory authorities. (Credit: Novo Nordisk A/S)
Novo Nordisk announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending marketing authorisation for Awiqli (the brand name for once-weekly basal insulin icodec) for treatment of diabetes in adults.
The positive CHMP opinion is based on results from the ONWARDS phase 3a clinical trial programme. Once-weekly basal insulin icodec achieved superior blood sugar reduction1 (measured by a change in HbA1c) and superior Time in Range2 (time spent within recommended blood sugar range), compared with daily basal insulin in people with type 2 diabetes. In people with type 2 diabetes who have not previously been treated with insulin, overall observed rates of clinically significant or severe hypoglycaemia3 were below one event per patient-year of exposure with both once-weekly basal insulin icodec and comparators.
In people with type 1 diabetes, once-weekly basal insulin icodec demonstrated non-inferiority in reducing HbA1c with a statistically significant higher estimated rate of severe or clinically significant hypoglycaemia compared with insulin degludec. Across the programme, once-weekly basal insulin icodec appeared to have a safe and well-tolerated profile.
“We believe that by reducing the number of basal insulin injections from seven to one per week, Awiqli has the potential to have a significant impact and improve treatment for people living with diabetes,” said Martin Holst Lange, executive vice president for Development at Novo Nordisk. “We are committed to driving innovation in diabetes treatment, and Awiqli has the potential to become the insulin of choice for people with type 2 diabetes initiating insulin treatment.”
Novo Nordisk expects to receive final marketing authorisation from the European Commission within approximately two months.
Source: Company Press Release