Novo Nordisk has announced that the European Medicine Agency’s advisory committee has recommended Awiqli (once-weekly basal insulin icodec) to treat diabetes in adults.

The recommendation from the Committee for Medicinal Products for Human Use (CHMP) was based on positive results from the phase 3a ONWARDS clinical trial programme.

Estimated to affect 415 million people worldwide, diabetes is a chronic disease that occurs when the pancreas does not produce enough insulin, a hormone that regulates glucose, or when the body cannot effectively use the insulin it produces.

Awiqli works to cover the basal insulin requirements for a week with a single subcutaneous injection.

Comprising six phase 3a global clinical trials involving more than 4,000 adults with type 1 or type 2 diabetes, the ONWARDS clinical development programme investigated the efficacy and safety of Awiqli.

Results from the programme showed that Awiqli achieved a superior blood sugar reduction and superior time in range compared with daily basal insulin in patients with type 2 diabetes, while maintaining a well-tolerated safety profile.

The overall observed rates of clinically significant or severe hypoglycaemia (low blood sugar) were below one event per patient-year of exposure with Awiqli in adults with type 2 diabetes who had not been previously treated with insulin.

For patients with type 1 diabetes, Awiqli demonstrated non-inferiority in reducing haemoglobin with a statistically significant higher estimated rate of severe or clinically significant hypoglycaemia compared with insulin degludec.

The company said it expects to receive final marketing authorisations from the European Commission within two months.

Martin Holst Lange, executive vice president, development, Novo Nordisk, commented: “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.”

Results from the clinical programme have shown that “Awiqli has the potential to become the insulin of choice for people with type 2 diabetes initiating insulin treatment,” added Lange.

Earlier this month, Novo Nordisk shared positive results from a phase 3 FLOW trial evaluating semaglitude for the prevention of kidney disease-related events in people with type 2 diabetes and chronic kidney disease.

https://pmlive.com/pharma_news/novo-nordisks-awiqli-recommended-by-chmp-to-treat-diabetes-in-adults/