Roche to Pull FDA Application
For Weight-Loss Drug Xenical
Dow Jones Newswires
BASEL -- With weight-loss drugs receiving renewed scrutiny, Roche
Holding AG's F. Hoffmann-La Roche Ltd. unit said Thursday it will
withdraw its new drug application in the U.S. for its obesity drug Xenical,
currently under review by the U.S. Food and Drug Administration.
In May, an FDA advisory committee unanimously recommended the
approval of Xenical. The FDA panel said that the data supported Xenical's
efficacy, but asked Roche to gather further information on breast cancer
cases observed in clinical trials. While Roche said it believes there is no
association of Xenical with breast cancer, it said it would make every
effort to answer any remaining questions from the FDA.
By withdrawing the application for now, Roche said it intends to submit
further analyses of available data to secure approval. Roche said it plans to
resubmit the application in the next several months.
If approved, Xenical would be the first obesity drug that blocks the
absorption of dietary fat, rather than suppress the appetite of dieters. Some
industry analysts estimated Xenical's U.S. sales could top $700 million by
2001.
The drug is the first pancreatic lipase inhibitor reviewed by the FDA.
Taken three times a day with meals, it blocks intestinal enzymes from
absorbing as much as 30% of the fat eaten. The fat goes straight to the
colon for excretion from the body. Xenical can cause gastrointestinal
problems, particularly in patients who ingest too much fat.
The withdrawal came on the heels of an editorial in Thursday's New
England Journal of Medicine calling for a moratorium on the use of
prescription diet drugs Redux and a combination of two other medicines
called "phen-fen" for cosmetic weight loss.
The New England Journal's editorial
harshly criticized the rationale the FDA
used last year to approve Redux,
which was developed by Interneuron
Pharmaceuticals Inc. of Lexington,
Mass., and marketed by the giant U.S.
drug maker, American Home Products Corp., Madison, N.J. The editorial
argued that the obesity drug's purported life-prolonging benefits were not
proved and may not outweigh the risks of side effects for all but the
seriously obese.
Nearly 35% of U.S. adults are overweight, up from 25.5% in the 1970s,
according to the Centers for Disease Control. Former Surgeon General C.
Everett Koop contends that obesity-related diseases take about 300,000
lives a year and are the second-leading cause of death in the U.S., behind
smoking, which each year causes about 450,000 deaths.
-------
Frankly, neither Xenical nor Redux are good drugs, from a diet perspective. Xenical may limit absorption of fat-soluble vitamins, like A, D & E. Also, it's excessive calories that make people gain weight, not merely fat. Patients can eat no fat and still get fat. People who take Xenical may get a false sense of security, thinking that if they block some fat absorption they'll lose weight; meanwhile they eat an entire box of sugar-loaded fat-free Snackwells, which have more calories than the original version.
And Redux may curb appetites, but if patients eat junk to begin with, they'll still gain weight. It just means they'll eat 4 twinkies instead of 6.
Until someone invents a drug that makes people exercise and eat nutritiously, drugs won't be the answer to obesity. However, considering that the American public and popular press would rather believe hype than truth, Xenical should be a bigger hit than Redux.
Todd |
