Novo Nordisk (NYSE:NVO) has disclosed that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion, recommending the marketing authorization of once-weekly basal insulin icodec for the treatment of diabetes in adults, to be marketed under the brand name Awiqli.
This positive opinion stems from the comprehensive phase IIIa ONWARDS program, comprising six global clinical trials involving over 4,000 adults with type 1 or type 2 diabetes. The trials evaluated the efficacy and safety of once-weekly basal insulin icodec, demonstrating superior blood sugar reduction and improved time spent within the recommended blood sugar range compared to daily basal insulin in type 2 diabetes patients.
Furthermore, clinically significant or severe hypoglycemia rates were observed to be below one event per patient-year of exposure with once-weekly basal insulin icodec and comparators in type 2 diabetes patients not previously treated with insulin. While non-inferiority in reducing blood sugar levels was established, a statistically significant higher estimated rate of severe or clinically significant hypoglycemia was noted compared to insulin degludec.
Pending final approval from the European Commission, expected within approximately two months, the addition of once-weekly basal insulin icodec to Novo Nordisk’s diabetes portfolio is anticipated to further bolster the company’s standing in the diabetic treatments market.
Over the past year, Novo Nordisk has demonstrated an improvement in its global diabetes value market share, reaching 33.8% from 31.9%, attributed to market share gains in both North America and international operations.
Additionally, recent milestones include the successful completion of the first phase IIIa study with IcoSema, a once-weekly combination of basal insulin icodec and semaglutide, as well as a phase I study with oral amycretin. However, the regulatory review for insulin icodec by the FDA has been extended by three months following the submission of data considered a major amendment to the biologics license application, with completion anticipated in the third quarter of 2024.
Novo Nordisk’s shares have surged by 71.9% in the past year, largely driven by the success of its obesity drug Wegovy (semaglutide 2.4 mg), which received FDA approval in 2021. The company recently received FDA approval for an expanded label for Wegovy, aimed at reducing the risks of major adverse cardiovascular events in adults with overweight or obesity and established cardiovascular disease. In 2023, Wegovy generated sales worth DKK 31.3 billion, reflecting substantial year-over-year growth.
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