FDA Panel's Vote Over Weight-Loss Drug Xenical
Results in Tie
March 16, 1998
BASEL, SWITZERLAND
Xenical:
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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.
