Novo’s Kyinsu Wins EU Approval for Type 2 Diabetes, a Once-Weekly Combo First

Novo Nordisk A/S (NYSE: NVO) announced that the European Commission (EC) has granted marketing authorization for Kyinsu (once‑weekly IcoSema), a fixed‑ratio combination of basal insulin icodec and GLP‑1 RA semaglutide, as an adjunct to diet and exercise for adults with Type 2 Diabetes Mellitus inadequately controlled on basal insulin or GLP‑1 therapy, based on the COMBINE Phase IIIa trial program demonstrating superior HbA1c reduction vs. individual components.

Regulatory Milestone

Drug Profile

• Mechanism: Fixed‑ratio combination of once‑weekly basal insulin icodec and once‑weekly GLP‑1 receptor agonist semaglutide
• Innovation: First and only once‑weekly injection combining basal insulin + GLP‑1 RA, reducing injection frequency from daily to weekly
• Dosing: Single subcutaneous injection vs. separate daily basal insulin + weekly GLP‑1 or multiple daily basal‑bolus injections
• Clinical Benefits: Superior glycemic control, pronounced weight loss, lower severe hypoglycemia rate vs. basal‑bolus regimen

Clinical Evidence – COMBINE Program

Market Impact & Outlook

• Reimbursement Path: EC approval triggers national pricing negotiations; expected broad reimbursement given Novo’s established payer relationships
• Manufacturing: Leverages existing semaglutide and icodec production capacity; minimal incremental capex required
• Global Expansion: U.S. FDA submission H1 2026; filing in China (world’s largest diabetes market) expected H2 2026

Forward‑Looking Statements
This brief contains forward‑looking statements regarding Kyinsu’s commercial launch, market penetration, and global regulatory pathway. Actual results may differ materially due to risks including pricing negotiations, competitive responses, and real‑world adoption rates.-Fineline Info & Tech