On May 24, an FDA advisory committee will meet to discuss the safety profile of Awiqli (insulin icodec), Novo Nordisk's long-lasting insulin, after a study showed the drug poses an increased risk of hypoglycemia to users.
Awiqli is an experimental therapy intended for diabetic adults with weekly doses, according to a briefing document for the advisory committee. In a phase 3 trial comparing Awiqli to Tresiba (insulin degludec) — Novo Nordisk's FDA-approved daily insulin product — the research found Awiqli patients had higher rates of clinically significant or severe hypoglycemic episodes.
The study did not find additional glycemic control or other benefits in Awiqli.
"Novo Nordisk remains confident in the potential of once-weekly insulin icodec to help those living with diabetes needing insulin," a spokesperson told Becker's. "We continue to work closely with the FDA as it completes the reviews needed to bring this important medicine to the diabetes community."
The spokesperson added that the company expects the FDA to make a final decision on the candidate in July.