Novo Nordisk's Victoza Awaits Final FDA Approval For Diabetes and Obesity

The drug has been seeing a bit of success in Europe and the announcement was made it is at the final stage for approval from the FDA. BD

Novo Nordisk’s CEO, Lars Sorensen, told Reuters at the Reuters Health Summit in New York that the new diabetes drug Victoza has reached the final decision stage at the U.S. FDA. Sorensen expects the drug will be approved, although “potentially all the outcomes are still possible. A rejection is still possible, a demand for refilling is still possible…”

According to Sorensen, Victoza, which was approved in Europe in July, has been achieving rapid uptake in Europe and is set to overtake Eli Lilly’s and Amylin Pharmaceuticals Inc’s rival Byetta treatment in Germany by the end of the year.

The final FDA verdict is expected this month or next.

Novo also sees a future for the Victoza in treating obesity. The drug has produced impressive weight loss results in mid-stage Phase II clinical trials, but final Phase III obesity studies have been put on hold pending the final decision by the FDA.