Novo CEO hopeful on Victoza approval

By Ben Hirschler

NEW YORK (Reuters) - Novo Nordisk's (NOVOb.CO) new diabetes drug Victoza has reached the final decision stage at the U.S. Food and Drug Administration and approval is the most likely outcome, the group's chief executive said on Wednesday.

Lars Sorensen, who heads the world's biggest producer of insulin, also said the drug was achieving rapid uptake in Europe and was set to overtake Eli Lilly's (LLY.N) and Amylin Pharmaceuticals Inc's (AMLN.O) rival Byetta treatment in Germany by the end of the year.

The delays facing Victoza in the all-important U.S. market have cast a shadow over the Danish drugmaker's prospects this year, as U.S. regulators pore over safety data for the injectable medicine.

"Potentially all the outcomes are still possible. A rejection is still possible, a demand for refiling is still possible, and an approval is, of course, possible -- we would submit more likely than the other outcomes," he told the Reuters Health Summit in New York.

"The potential benefits of this drug clearly outweigh any risk."

A final FDA verdict is expected this month or next.

"Our U.S. affiliates had daily communications with the division of biologics at the FDA and it has come down to the final decision," Sorensen said.

He still believes the drug has blockbuster potential, meaning annual sales of more than $1 billion.