Novo Nordisk’s once-weekly diabetes combo drug wins EU support after U.S. setback

The EU's drug advisory body, CHMP, endorsed Kyinsu, Novo Nordisk’s once-weekly combo therapy for Type 2 diabetes, after a previous FDA rejection.

Why it matters: The recommendation paves the way for expanded access to a simplified diabetes treatment regimen across Europe, especially for patients struggling with standard insulin or GLP-1 therapies.

Backstory: Kyinsu combines weekly basal insulin Awiqli (icodec) and semaglutide (Ozempic). The FDA rejected icodec in 2024 over manufacturing concerns and hypoglycemia risks in Type 1 diabetes, prompting Novo to pull its U.S. application for the combination drug.

Big picture: The CHMP’s support marks a potential turning point for Novo’s weekly insulin strategy and highlights the EU’s growing flexibility on combo therapies. This move also contrasts with more cautious U.S. regulatory decisions on novel insulin formulations.