BASEL, SWITZERLAND March 16, 1998
The United States Food and Drug Administrations 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®
(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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