The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will meet on May 24 to discuss Novo Nordisk’s application for a once-weekly insulin.
The drug candidate, insulin icodec, is designed to reduce patients’ basal insulin injections from seven a week to just one. But in December, the FDA told Novo it would need an extra three months to review the application because of new data that constituted a “major amendment,” according to the company.
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended an approval last month based on Phase 3 data showing a once-weekly injection of icodec was superior at reducing blood sugar and keeping it in an acceptable range compared to daily insulin. If approved, the drug would be marketed in Europe as Awiqli.
Novo said in January that it anticipates an FDA decision in the third quarter of this year.
“We look forward to participating in these discussions with the committee and are confident in the potential of once-weekly basal insulin icodec to help manage diabetes for people who require insulin,” a Novo spokesperson told Endpoints News on Monday.