New Drug, the Magic Bullet for Obesity?
Half the patients lost 5 percent of their body weight
and one-quarter lost 10 percent of their body weight.
While testing a drug for Lou Gehrig's disease in
the mid-1990s, scientists noticed that people receiving
the drug were losing weight. It was an unexpected
and unwanted side effect.
They eventually concluded that the medication wasn't
helpful for people with the degenerative motor neuron
disease, but they didn't forget their finding.
Today,
the drug, Axokine, is poised to become the next
prescription weight-loss medication. In January,
the Food and Drug Administration gave it "fast
track" status because, by facilitating weight
loss, it could reduce the risk for heart attack,
stroke and diabetes in obese people. The designation
means the agency will expedite the drug's review.
Studies on Axokine indicate that most people taking
the drug experience weight loss for a few months.
Over a longer period of time, only about one-third
of people taking the drug continue to experience
weight loss, but for them, the loss can be dramatic.
Although Axokine is still under investigation and
is probably a few years from the marketplace, it
would offer a new approach to treating obesity. Axokine
is a modified form of a naturally occurring protein,
called ciliary neurotropic factor, that acts in the
brain to inhibit hunger signals. Initially, scientists
believed that patients with Lou Gehrig's disease
might be helped because ciliary neurotropic factor
promotes the survival of nerve cells.
"The hypothalamus, the master gland of the
brain, is the Grand Central Station where information
on energy intake, expenditure and reserves all converge," said
Dr. Leonard S. Schleifer, president and chief executive
of Regeneron Pharmaceuticals, which developed the
drug. "Our protein acts by telling the brain
that it has enough food and to eat less."
Axokine also seems to prevent the overeating that
occurs when the brain responds to a restricted food
intake -- the well-known rebound effect many dieters
experience, said Schleifer.
Two-thirds of people who take the drug, however,
become resistant to it. Regeneron has a blood test
that, Schleifer said, can show who will continue
to benefit from taking the drug.
"Overall, everyone appears to benefit for a
few months," he said. "But thereafter,
some people continue to benefit and others don't.
In two-thirds of people, their immune system seems
to reject this treatment."
A small study published in April in the Journal
of the American Medical Association showed that most
Axokine users experienced continuous weight loss
during 12 weeks of use. A preliminary report on a
larger study -- more than 1,400 people taking the
drug for one year -- found that among the 30 percent
of people who did not develop resistance to the drug,
half lost 5 percent of their body weight and one-quarter
lost 10 percent of their body weight. This result
is similar to the effects of prescription obesity
drugs already on the market.
Finally, a 12-week study on overweight and obese
people with diabetes, reported last week, found that
patients receiving Axokine and dietary counseling
lost 61/2 pounds compared to 21/2 pounds among people
receiving only dietary counseling.
Eventually, the drug will be tested in about 4,000
people, according to a Regeneron spokeswoman.
The medication, which patients give themselves in
an injection under the skin, appears safe in the
studies completed thus far. The company is working
on a pill version of Axokine.
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