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Novo Nordisk’s Awiqli® (insulin) Recommended for EU Approval

Mar 22, 2024

On 22 March 2024 Novo Nordisk announced that it has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for Awiqli® (once-weekly basal insulin icodec) to treat diabetes in adults.

Once-weekly Awiqli® dosing demonstrated superior blood sugar reduction and time spent within the recommended blood sugar range compared to daily basal insulin in type 2 diabetes patients. For those not previously treated with insulin, rates of clinically significant or severe hypoglycemia were low. In type 1 diabetes patients, Awiqli® was non-inferior in reducing HbA1c but showed a higher rate of severe or clinically significant hypoglycemia compared to insulin degludec. The drug appeared safe and well-tolerated across the program.

Novo Nordisk anticipates final marketing authorisation from the European Commission in the coming months.

This news comes soon after Novo Nordisk announced that the FDA approved a label expansion for Wegovy® for reducing risks of major adverse cardiovascular events.

This news also follows on the 5 February 2024 announcement by Novo Holdings (Novo Nordisk’s parent company) that it will acquire global contract development and manufacturing company Catalent for USD $16.5B.