EU Approves Novo Nordisk’s Groundbreaking Once-Weekly Basal Insulin Icodec for Adults with Diabetes

1. The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on March 21, 2024, recommending marketing authorization for Novo Nordisk's once-weekly basal insulin called Awiqli (brand name for insulin icodec).
2. Awiqli demonstrated superior blood sugar reduction (HbA1c) and superior time spent within the recommended blood sugar range (Time in Range) when compared to daily basal insulin in individuals with Type 2 diabetes.
3. In Type 1 diabetes, Awiqli showed non-inferiority in reducing HbA1c but exhibited a higher rate of severe or clinically significant hypoglycemia compared to insulin degludec.
4. The ONWARDS clinical development program involved over 4,000 adults with Type 1 or Type 2 diabetes across six phase 3a global clinical trials.
5. The European Commission is expected to issue final marketing authorization for Awiqli within approximately two months.
6. Awiqli is available as a 700 U/mL solution for injection in pre-filled pens and is primarily indicated for treating diabetes mellitus in adults, with caution suggested for Type 1 diabetics due to increased risk of hypoglycemia.