UPDATE 2-Novo Nordisk says US approves Victoza

* Drug cleared for treatment of type 2 diabetes in U.S.

* To launch Victoza in U.S. within weeks

(Adds details from FDA statement)

NEW YORK, Jan 25 (BestGrowthStock) – Novo Nordisk (NOVOb.CO: ) said
U.S. health officials approved its Victoza drug for treatment
of type 2 diabetes and that it would launch the drug in the
United States within weeks.

The Danish drugmaker said Victoza, also known as
liraglutide, is meant to help lower blood sugar levels along
with diet and exercise in adults with type 2 diabetes.

“The U.S. approval of Victoza represents a major
advancement in the treatment of type 2 diabetes and is an
important milestone for Novo Nordisk,” Lars Rebien Sorensen,
Novo’s chief executive, said in a statement on Monday.

Novo Nordisk has said Victoza has the potential to be a
blockbuster drug, meaning annual sales of more than $1 billion.

The drug had faced delays after a Food and Drug
Administration advisory panel that met in April 2009 raised
questions about the medicine’s safety.

The FDA said the drug’s benefits of controlling blood sugar
outweighed its risks but it was requiring further study after
approval of some safety issues.

In clinical trials, pancreatitis occurred more often with
Victoza compared with other diabetes drugs. The agency said the
drug should be stopped if patients develop severe abdominal
pain and should not be restarted if blood tests confirm
pancreatitis.

The FDA said it was requiring the company to conduct a
post-approval study to test Victoza’s cardiovascular safety in
a higher-risk group of patients. No increase in heart problems
was seen in the mainly low-risk patients in clinical trials.

Novo Nordisk also must do a five-year study to evaluate the
risks of thyroid and other cancer risks, seriously low blood
sugar levels, pancreatitis and allergic reactions.

It is not known if Victoza causes thyroid cancers, the FDA
said. In studies, the drug caused thyroid tumors in rats and
mice. Cancerous tumors were increased in rats given doses eight
times higher than people would receive, the FDA said.

The FDA said Victoza should not be used as a first-choice
treatment for diabetes unless other studies support such use.

Victoza will compete with Byetta, the rival treatment from
Eli Lilly and Co (LLY.N: ) and Amylin Pharmaceuticals Inc
(AMLN.O: ).

Victoza and Byetta both belong to the GLP-1 class of drugs
that stimulate insulin release when glucose levels become too
high. Other GLP-1 drugs are also being developed by rival
drugmakers, such as GlaxoSmithKline Plc (GSK.L: ) and Roche
Holding AG (ROG.VX: ).

In addition to treating diabetes, Novo also sees a
long-term future for Victoza in treating obesity.

Victoza produced weight loss in mid-stage clinical trials,
but final obesity studies have been put on hold pending the
FDA’s decision on diabetes.

Stock Analysis

(Reporting by Martinne Geller and Lisa Richwine; Editing by
Anshuman Daga)

UPDATE 2-Novo Nordisk says US approves Victoza