Novo seeks U.S. approval for new Victoza usage

COPENHAGEN, June 28 Tue Jun 28, 2011 10:36am EDT

COPENHAGEN, June 28 (Reuters) - Danish drugmaker Novo Nordisk (NOVOb.CO) is applying for U.S. approval for use of its diabetes drug Victoza in combination with long-acting insulins.

Spokesman Mike Rulis declined to say on Tuesday how long Novo Nordisk expected the review process to take.

Victoza has been approved by a number of different regulatory agencies as a once-daily injection for the treatment of adults with type 2 diabetes. It is not an insulin, but rather a human GLP-1 (Glucagon-Like Peptide-1) analogue that stimulates the body's own release of insulin.

Long-acting insulins on the market include Novo Nordisk's own Levemir and French rival Sanofi-Aventis's Lantus.

"The study that forms the basis for (this application) was a study with our own long-acting insulin, Levemir," Rulis said.

Novo Nordisk presented new data on June 25 at the American Diabetes Association conference in San Diego, California, that showed Victoza in combination with Levemir helped patients reach and maintain blood sugar targets with low frequency of hypoglycaemia and to maintain weight loss. (Reporting by John Acher; Editing by Dan Lalor)