UPDATE: Novo Nordisk's Victoza Gets US Approval
January 26 2010 - 3:35AM
Dow Jones News
Shares in Novo Nordisk A/S (NOVO-B.KO) opened higher Tuesday
after the Danish pharmaceutical company said the U.S. Food and Drug
Administration has approved its drug Victoza for treatment of
type-2 diabetes.
The Copenhagen-based company said it expects to introduce
Victoza in the U.S. market within weeks.
However, it said the U.S. regulator requires that Victoza is
labelled with a warning for thyroid cancer.
In previous tests, the drug caused thyroid tumors in rodents
although there were no reported cancer cases in humans.
The U.S. marketing authorization also requires that patients and
health-care providers are informed about potential risks of
pancreatitis, Novo Nordisk said.
FDA approval allows Victoza to be used in the U.S. in
monotherapy, as a second-line treatment, and in combination with
oral diabetes drugs, the company said.
Victoza, also known as Liraglutide, was launched in European
markets in 2009, and gained regulatory approval in Japan last
week.
Analysts have seen a big commercial potential for Victoza, in
the U.S., in particular, which is the world's largest
pharmaceuticals market. Compared to diabetes treatment with
insulin, it doesn't risk pushing blood sugar too low and it also
helps patients lose weight.
An FDA expert panel in April last year came to a split decision
on whether Victoza, a synthetic hormone that stimulates insulin
production in the human body, was safe to be marketed after trials
showed an increased incidence of tumors in rats and mice.
The drug will face competition from rival treatments such as
Byetta LAR, which is expected to reach the market during 2010. Eli
Lilly & Co. (LLY) and Amylin Pharmaceuticals Inc. (AMLN)
partnered with Alkermes Inc. (ALKS) to develop Byetta LAR.
At 0802 GMT, shares in Novo Nordisk traded up 4.8% at DKK364,
outperforming a 1% rise in the wider market in Copenhagen.
-By Gustav Sandstrom, Dow Jones Newswires; +46-8-5451-3099;
gustav.sandstrom@dowjones.com
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