Novo’s Victoza Awaits Final FDA Approval


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 refiling 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.


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Danny Haszard
13 years ago

Eli Lilly sells a drug {ZYPREXA} that can cause diabetes and then turn a profit on the drugs that treat the condition that they may have caused in the first place! Eli Lilly has made $38 billion on Zyprexa and it was way oversold and caused diabetes and in some cases sudden death. Eli Lilly has received a huge criminal fine over their Zyprexa cash cow,add it all up comes to $4.6 billion, in Zyprexa settlements,fines,litigation.   Did you know that Lilly made $ billions last year on diabetic meds, Actos,Humulin and Byetta? Yes! They sell a drug that can… Read more »

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