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BETHESDA, Md., May l4, 1997.
The Food and Drug Administration's (FDA) Endocrinology and
Metabolic Drugs
Advisory Committee today unanimously recommended the approval
of Xenical®
(orlistat) to help people lose weight and decrease other health
risks. Xenical was
discovered and developed by Hoffmann-La Roche.
Xenical (pronounced: zen-i-cal) represents the first of a new
class of
non-systemic, anti-obesity drugs called lipase inhibitors, or
fat blockers, which act
in the gastrointestinal tract to prevent the absorption of fat
by about 30 percent.
Drugs in this class do not achieve their effect through brain
chemistry.
According to the data presented, almost three times as many
patients on Xenical
with a moderately reduced calorie diet lost 10 percent or more
of body weight
compared to placebo with diet. Nearly twice as many patients on
Xenical lost at
least 5 percent of body weight compared to placebo with diet.
The average patient in the one-year clinical trials weighed
220 pounds and lost 20
pounds, or about 10 percent of body weight, after taking Xenical
and being on a
moderately reduced calorie diet. Many patients who continued into
the second
year of the studies were able to keep off the lost weight.
In addition, 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.
Efficacy From Comprehensive Clinical Program
The Advisory Committee's recommendation was based on double-blind,
placebo-controlled and randomized studies involving more than
4,000 patients
conducted in the U.S. and Europe.
In the clinical trials, people took Xenical orally in 120 mg
capsules three times
daily in conjunction with a moderately reduced calorie diet containing
30 percent
fat. Because low vitamin levels are an existing problem among
the overweight
and obese population, people following a moderately reduced calorie
diet,
including those using Xenical, should be sure they have adequate
vitamin intake
through supplementation.
Data Support Tolerability and Quality of Life Improvement
The clinical trials showed that Xenical was well-tolerated.
The most common side
effects reported were non-systemic and were primarily gastrointestinal.
These
effects generally occurred early in treatment and were self-limited
and of short
duration in most cases. Roche supports the Advisory Committee
recommendation to continue studying the long-term effects of Xenical.
Data provided to the Advisory Committee found statistically
significant
improvements in patient quality of life measurements, including
overweight
distress and satisfaction with treatment.
Headquartered in Nutley, New Jersey, Hoffmann-La Roche Inc.
is an affiliate of
the multinational group of companies headed by Roche Holding Ltd.
of Basel,
Switzerland. One of the world's leading research-intensive companies,
Roche has
discovered, developed and introduced numerous innovative prescription
pharmaceuticals designed to fulfill unmet medical needs.
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