Novo Nordisk AS's new diabetes drug Awiqli receives regulatory recommendation from the European Union, requiring only one injection per week

On March 21st, Novo Nordisk AS announced that the European Medicines Agency (CHMP) has recommended the approval of its innovative diabetes treatment drug Awiqli (icodec insulin) for the treatment of adult diabetes. Awiqli is a new type of basal insulin that only needs to be injected once a week, providing a more convenient treatment option for diabetes patients.

Overnight, Novo Nordisk AS's stock price slightly increased after the market opened.

Awiqli's approval is based on the ONWARDS series of Phase 3a clinical trials, which aimed to evaluate the drug's efficacy and safety in different types of diabetes patients. The trial results showed that Awiqli performed excellently in lowering blood sugar levels, with good safety and tolerability.

For type 2 diabetes patients, Awiqli showed better performance in lowering blood sugar levels compared to daily injected basal insulin. Additionally, for type 2 diabetes patients who have not used insulin before, the incidence of severe hypoglycemia with Awiqli was very low.

However, for type 1 diabetes patients, although Awiqli is comparable to insulin degludec in lowering blood sugar, there may be a higher risk of hypoglycemia.

Martin Holst Lange, Executive Vice President of Development at Novo Nordisk AS, stated: "We believe that Awiqli allows diabetes patients to only need to inject insulin once a week instead of daily. The once-weekly injection regimen of Awiqli will provide a more convenient treatment option for diabetes patients, reducing their burden. Awiqli has the potential to become the preferred drug for type 2 diabetes patients who need to start insulin therapy."

Novo Nordisk AS expects to receive formal approval from the European Commission in approximately two months, at which point Awiqli will be available for sale in the European market