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FDA Panel’s Vote Over Weight-Loss Drug Xenical Results in Tie
BASEL, SWITZERLAND March 16, 1998
The United States Food and Drug Administration’s endocrinologic and metabolic
drugs advisory committee is deadlocked at five to five on recommending
approval of F. Hoffmann-La Roche Ltd.’s weight management drug Xenical(R)
(orlistat).
Roche said it would meet shortly with the FDA staff to discuss the recommendation.
Roche reaffirms its belief that orlistat has an important role to play
in the management of obesity and looks forward to discussing next steps
with the FDA.
In May 1997 the panel unanimously recommended the approval of Xenical,
a lipase inhibitor which acts in the gastrointestinal tract to decrease
fat absorption by about 30 percent. Drugs in this class do not achieve
their effect through brain chemistry.
Previous studies showed that Xenical-treated patients had statistically
significant reductions in total and LDL cholesterol and systolic and diastolic
blood pressure, as well as improvements in blood concentrations of glucose
and insulin after one year over placebo with diet.
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