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# Novo Nordisk's Awiqli Recommended for Approval by European Regulatory Authorities
- URL: https://www.pharmamanufacturingiq.com/novo-nordisk-s-awiqli-recommended-for-approval-by-european-r/
- Published: 2024-03-22T10:44:00.000Z
- Updated: 2026-10-08T12:45:37.000Z
- Description: Novo Nordisk have announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended marketing authorisation for Awiqli for treatment of diabetes in adults.
- Author: PharmaManufacturing IQ Staff
- Tags: Drug Development & Approvals, News

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[Novo Nordisk](https://www.novonordisk.com/?ref=pharmamanufacturingiq.com) have announced that the European Medicines Agency’s [Committee for Medicinal Products for Human Use](https://www.ema.europa.eu/en/committees/committee-medicinal-products-human-use-chmp?ref=pharmamanufacturingiq.com#:~:text=The%20Committee%20for%20Medicinal%20Products,medicines%20in%20the%20European%20Union.) (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 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](https://www.linkedin.com/in/martin-holst-lange-21662612/?originalSubdomain=dk&ref=pharmamanufacturingiq.com). “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.