Novo Nordisk Awiqli recommended for approval for diabetes by European regulatory authorities

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 reduction (measured by a change in HbA1c) and superior Time in Range (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 hypoglycaemia 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.

Awiqli is a once-weekly basal insulin analogue designed to cover the basal insulin requirements for a full week with a single subcutaneous injection.

The ONWARDS clinical development programme comprised six phase 3a global clinical trials, which investigated the efficacy and safety of once-weekly basal insulin icodec, involving more than 4,000 adults with type 1 or type 2 diabetes, including a trial with real-world elements.

Novo Nordisk is a global healthcare company, founded in 1923 and headquartered in Denmark. The Company markets its products in around 170 countries. Novo Nordisk's B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO).