(Reuters) - Novo Nordisk's
big-selling diabetes drug Victoza appears to be an
effective weight loss therapy, data from a late-stage
clinical trial presented on Saturday demonstrated.
In the 56-week study of 846 overweight or obese adults with type 2
diabetes, a daily injection of 3 milligrams of Victoza led to
significantly greater weight loss than did a placebo.
Patients taking the 3 mg dose of the drug, known chemically as
liraglutide, had a mean loss of 5.9 percent of body weight. That
compared with a loss of 4.6 percent for a 1.8 mg dose and just 2
percent loss for those who got a placebo. All patients were also put
on a diet and exercise program.
The results were presented at the American Diabetes Association
meeting in San Francisco.
Weight loss had been viewed as a beneficial side effect of Victoza
as obesity is a leading cause of type 2 diabetes. But with obesity
becoming a global health crisis, Novo Nordisk now sees the medicine
as a potentially lucrative weight loss drug at a higher than
currently approved dose. Some two thirds of Americans are classified
as overweight or obese.
Victoza had global sales of about $542 million in the first quarter.
Danish drugmaker Novo Nordisk is awaiting approval decisions from
U.S. and European regulators for 3 mg liraglutide for weight loss.
It is approved to treat type 2 diabetes in the United States at 1.2
mg and 1.8 mg.
In the study, called Scale, 50 percent of patients taking 3 mg
Victoza lost at least 5 percent of body weight and 22 percent
dropped more than 10 percent.
On that measure, "it stacks up very favorably against other
medications that are out there or likely to be approved," Dr. Robert
Kushner, an obesity specialist and one of the trial's investigators,
said in a telephone interview.
The efficacy should easily satisfy U.S. Food and Drug Administration
weight loss drug criteria, leaving safety as the main hurdle to
approval. A lively debate is likely when a panel of experts meets in
September to discuss the drug before the FDA makes a decision.
The FDA has defended Victoza's safety against calls for its removal
from the market by consumer watchdog Public Citizen, which says it
raises the risk of thyroid cancer and pancreatitis.
Kushner said there were no cases of either during the trial. He
believes the benefits outweigh the drug's risks.
"We currently cannot predict who's going to respond to which
medication and that's why it's so helpful to have multiple
medications," he said. "Even individuals without diabetes may be
very responsive to this hormonal approach", compared with drugs that
work on the brain to suppress appetite, he added.
There was a 9.2 percent drop out rate in the 3 mg group, with more
than half due to gastrointestinal disorders, such as nausea and
diarrhea, which are common to drugs in this class.
Nausea typically diminishes after four to eight weeks, Kushner said.
(Reporting by Bill Berkrot; Editing by Peter Galloway)