Approvals

This positive CHMP opinion follows results from the ONWARDS phase 3a clinical trial programme, in which patients treated with Awiqli achieved superior blood sugar reduction and superior time in range, compared to those treated with daily basal insulin for type 2 diabetes. In patients with type 1 diabetes, the drug demonstrated non-inferiority in reducing HbA1c with a statistically significant higher estimated rate of severe or clinically significant hypoglycaemia compared with insulin degludec.

The drug had a safe and well tolerated safety profile across the clinical programme.

Martin Holst Lange, executive vice president for development at Novo Nordisk, commented: “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. 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’, according to the company’s press release.