FDA Advisory Committee Unanimously Recommends Xenical for
Weight Loss
May l4, 1997.
Xenical:
Prices and Ordering Information
The Food
and Drug Administration's (FDA) Endocrinology and Metabolic
Drugs Advisory Committee today unanimously recommended the
approval of Xenical(R) (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.
