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Obesity Drug Guidance Must Include Kids - Panel
Quote:
Obesity Drug Guidance Must Include Kids - Panel
Wed Sep 8, 6:16 PM ET
By Susan Heavey
BETHESDA, Md. (Reuters) - U.S. experts said on Wednesday that companies developing fat-fighting drugs should include severely obese children in their studies but were less supportive of targeting moderately overweight adults without health problems.
Panelist Dr. Lynne Levitsky, head of pediatric endocrinology at Massachusetts General Hospital, said a "higher assurance of safety" would be needed before including people who are heavy but not obese.
In 1997 the Food and Drug Administration had to pull Wyeth's so-called "fen-phen" cocktail from the market after it was linked to heart troubles.
The members of a FDA advisory committee were more certain that drug makers should include children in their research, but only those with a high body mass and severe health problems.
"This population of patients needs to be studied separately from the adults," said Dr. Glenn Braunstein, acting committee chairman and head of medicine at Cedar-Sinai Medical Center in Los Angeles, told a public meeting of the panel.
The incidence of obesity has soared in the United States, particularly among children, and the race is on to find new drugs to fight fat.
Dozens of weight-loss drugs are under development, but only two are close to being submitted to the FDA -- Sanofi-Aventis' Acomplia and Regeneron's Axokine.
The advisers have been asked by the FDA to review its 1996 draft guidelines for weight-loss drug trials and suggest any changes.
A handful of drugs are currently approved to treat obesity, including Abbott Laboratories' Meridia and Roche Holding AG's Xenical.
Research has shown 40 percent of youth are overweight or at risk of becoming too heavy, which can lead to a higher risk of diabetes, heart disease and other problems even in children.
Nearly two-thirds of adults are also overweight, and half of them are considered obese, according to U.S. government statistics.
The FDA does not anticipate "that there's anything in the pipeline that is going to be dramatically more effective than what we've seen already," said Dr. David Orloff, head of the division that includes weight-related drugs.
Many companies had urged the FDA to limit safety trials to one year, but panelists were mixed as to whether a second year was needed, as called for in the draft guidelines.
FDA's Orloff said the agency prefers longer, larger trials, especially since officials had "made some bad decisions to approve some obesity drugs in the past."
Most panelists agreed with the draft definition of success as a 5 percent weight loss, although some drugmakers urged the FDA to consider the effect on cholesterol, blood pressure and other conditions linked to obesity.
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