The FDA has rejected Novo Nordisk’s once-weekly insulin icodec, citing concerns over the drug’s safety and efficacy. The decision comes as a setback for the Danish pharmaceutical company, which had hoped to introduce a more convenient treatment option for patients with type 2 diabetes.
Insulin icodec is a long-acting basal insulin analogue that requires only one injection per week, compared to the daily injections needed with current insulin treatments. Despite the potential benefits of reduced injection frequency, the FDA determined that the data provided by Novo Nordisk did not sufficiently demonstrate the safety and effectiveness of the drug.
As the FDA continues to evaluate new drug applications in 2024, BioSpace will keep you informed of all the latest decisions in the biotech and pharmaceutical industry. Stay tuned for updates on groundbreaking treatments and regulatory milestones.
