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Abbott spokesman Scott Davies said the appropriate candidate for Meridia is someone who's obese with no history of heart disease who can't lose weight with diet and exercise. He noted that most of the study's participants wouldn't be eligible to take it under its current label.
"We believe this is an important option for patients and physicians to treat a serious condition for which there are few treatments currently available," he said.
Meridia was approved in the U.S. in 1997 -- the same year the popular fen-phen drug combo was linked to heart valve problems and pulled from the market. Meridia use in the U.S. has been steadily declining in recent years, according to prescription data firm IMS Health. About 283,000 prescriptions for it were filled last year, just over half the number of prescriptions in 2005.
Davies said Abbot doesn't actively promote Meridia in the U.S. and he termed sales modest. The company expects global sales this year to be less than $100 million, including less than $30 million in the U.S., he said.
The drug, also known as sibutramine, is sold under a variety of names around the world.
An FDA advisory panel will review the study at a Sept. 15 meeting, while the next day it will consider approval of a new weight-loss drug, lorcaserin. Drugmakers have struggled to come up with a pill that doesn't have risky side effects. The panel voted against another experimental diet drug in July because of its side effects.
New England Journal: http://www.nejm.org/
Copyright 2010 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
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