Safety risk cited for Novo Nordisk's long-acting insulin

A long-acting insulin from Novo Nordisk was shown to have a greater risk of excessively lowering patients' blood sugar without offering better management of sugar levels or other benefits, Food and Drug Administration staff found.

Why it matters: European regulators in March endorsed the injection, which has been touted as the world's first once-weekly insulin and a key part of Novo's business line, along with its blockbuster drugs used for weight loss, Wegovy and Ozempic.

What they found: The FDA briefing document noted that late-stage trial data show patients with Type 1 diabetes who took the long-acting shot after a year had 50% to 80% more clinically significant or severe hypoglycemia than those who took a Novo daily insulin

• The period of highest risk occurred within two to four days of receiving the injection and coincided with the peak glucose-lowering effect of the drug.
• Novo suggested potential ways to support safe and effective use, including limiting the weekly insulin to patients with Type 1 diabetes who wear a continuous glucose monitor or reducing dosages.
• However, FDA staff said there wasn't clinical data to assess these risk mitigation strategies.

What's next: The FDA's Endocrinologic and Metabolic Drugs Advisory Committee is due to meet Friday to evaluate the Novo shot.

• Eli Lilly also is testing a once-weekly insulin in adults with Type 2 diabetes.