FDA Rejects Novo Nordisk’s Once-Weekly Insulin Icodec for Diabetes Treatment

1. FDA Rejection: The US Food and Drug Administration (FDA) has declined to approve Novo Nordisk's once-weekly insulin icodec for the treatment of diabetes, citing concerns about manufacturing processes and its use in type 1 diabetes patients.
2. Reasons for Rejection: The FDA's decision follows an advisory panel's vote against the use of icodec in type 1 diabetes patients due to concerns about the risk of low blood sugar.
3. Novo Nordisk's Response: The company will work closely with the FDA to address the concerns and does not expect to fulfill the requests this year.
4. Global Approvals: Icodec is already approved under the brand name Awiqli in several countries, including the EU, Canada, Australia, Japan, Switzerland, and China, for both type 1 and type 2 diabetes.
5. Impact: This rejection is a rare setback for Novo Nordisk, a leading global healthcare company specializing in diabetes treatments.