U.S. offers drugmakers advice on obesity drugs
February 19, 2007
WASHINGTON - As more Americans move violently with rising
waistlines, U.S. health officials on Wednesday set out their
own tips for drug makers seeking to develop products for
people trying to shed pounds.
The U.S. Food and Drug Administration's draft guidelines
-- more than 10 years in the making -- aim to help companies
develop and test new drugs and devices for treating obesity.
About a third of U.S. adults, or more than 60 million people,
are obese and another third are overweight,
government statistics show. Nearly a fifth of U.S. children
also weigh too much.
The FDA proposed that companies should prove their products
can help people lose weight and keep it
off for at least a year. It also urged them to study people
with a body mass index (BMI)of at least 30 or those with
a BMI of at least 27 with diabetes, heart disease or other
weight-related conditions.
BMI is determined by dividing weight by height. People
with a score of 25 to 29.9 are considered overweight and
those at 30 or higher are considered obese.
Overweight individuals are at risk for other, potentially
life-threatening problems. In addition to diabetes, high-blood
pressure and certain cancers are also possible.
Drugs usually aim to help people lose weight by curbing
their appetite or preventing fat absorption. Some devices,
such as Allergan Inc.'s Lab-Band, are used in surgical procedures
to limit stomach size.
Sanofi-Aventis is also awaiting the FDA's ruling on its
Acomplia drug, In a recent research note, Susquehanna Financial
Group analysts said they were "shocked" that just 17 companies
with weight-loss
products on the market or in advanced development, despite
"the large market opportunity (and) the health consequences
of no therapy.
The FDA gave no deadline for public comment on the proposal. An agency spokeswoman said the timing for the final guidelines would depend in part on the comments received
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