A representative from Novo Nordisk has recently announced that the company is planning to submit regulatory approval applications for its insulin icodec and semaglutide combination (IcoSema) in jurisdictions outside the US. The decision to file the applications reportedly follows completion of the Phase III COMBINE-1 study in Q2 2024 which demonstrated that the combination achieved its primary endpoint of superior blood sugar control after 52 weeks versus insulin icodec alone.
Novo Nordisk will not be seeking regulatory approval of IcoSema in the US at this stage following the issue of a Complete Response Letter (CRL) by the US FDA on 10 July 2024 regarding insulin icodec for diabetes mellitus.
Novo Nordisk’s insulin icodec was approved as Awiqli® in certain jurisdictions including Europe, Switzerland and Canada, Japan and Australia, and endorsed in China.