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Hoffmann-La Roche Inc. today announced
that the U.S. Food and Drug Administration (FDA) has granted
marketing approval of Xenical (orlistat). Xenical is the only
prescription lipase inhibitor and acts by blocking the absorption of
dietary fat by approximately 1/3. Xenical is indicated for obesity
management including weight loss and weight maintenance when used in
conjunction with a reduced-calorie diet. Xenical is also indicated
to reduce the risk for weight regain after prior weight loss. When
compared to diet alone, weight loss with Xenical also results in
measurable improvements in certain obesity-related conditions, such
as high blood pressure, high cholesterol and diabetes.
Unlike other anti-obesity agents that
work in the brain to suppress appetite, Xenical through its
fat-blocking mode of action works non-systemically in the
gastrointestinal tract, not requiring entry into the bloodstream or
brain. Xenical [pronounced: zen'-i-cal] will be available to
patients by prescription in the coming weeks." We believe that
Xenical will provide significant benefit to millions of obese
Americans," said Patrick J. Zenner, President and Chief Executive
Officer of Hoffmann-La Roche Inc., the U.S. pharmaceuticals
affiliate of Swiss-based Roche Holding Ltd. "Obesity is escalating
at epidemic rates in this country. Recognizing that long-term weight
loss success may depend on the integration of drug therapy with
diet, exercise and lifestyle modification, Roche is committed to
providing comprehensive support to all patients and health care
providers. Upon the availability of Xenical, Roche will also debut a
novel education and counseling initiative to ensure appropriate use
of Xenical.
Xenical is recommended for use three
times daily with meals that contain up to 30% fat, consistent with
current U.S. dietary guidelines. Blocking 1/3 of fat from digestion
means that a patient who ingests 60 grams of fat a day may absorb
only 40 grams of fat. The other 20 grams will be excreted through
the digestive tract.
Xenical is indicated for obese patients
with an initial body mass index (BMI) of greater than or equal to 30
or greater than or equal to 27 in the presence of other risk
factors, such as high blood pressure, high cholesterol, and
diabetes. Body mass index (BMI) is the most widely accepted
measurement of obesity. Xenical is contraindicated in patients with
chronic malabsorption syndrome or cholestasis. Organic causes of
obesity, such as hypothyroidism, should be excluded before
prescribing Xenical.
"We now recognize that excess fat
consumption is a contributor to health threats such as obesity and
its related risk factors," said Louis J. Aronne, MD, Director of the
Comprehensive Weight Loss Clinic, Cornell University Medical
College, and a principal investigator in the Xenical clinical
trials. "I believe that Xenical's unique mechanism of action and
efficacy value will play a critical role in the medical management
of patients with obesity-related risks." Xenical is currently
available in 17 other countries (Argentina, Austria, Belgium,
Brazil, Chile, Denmark, Finland, France, Germany, Italy, Mexico, The
Netherlands, New Zealand, Spain, Switzerland, Venezuela and UK) and
will soon be introduced in other worldwide markets. To date, more
than 1,000,000 patients have been treated with Xenical in these
countries.
Gastrointestinal symptoms are the most
commonly observed side effects associated with the use of Xenical
and are primarily a manifestation of its mechanism of action. These
effects are generally mild and transient and may include oily
spotting, flatulence with discharge, fecal urgency, fatty or oily
stool, oily evacuation, increased defecation and fecal incontinence.
Maintaining the recommended dietary regimen-containing up to 30% of
calories from fat-may minimize the occurrence of these
events.
Because Xenical partially blocks fat
absorption, it has been shown to reduce the absorption of the
fat-soluble vitamins A, D, E and K as well as beta-carotene.
Therefore patients are advised to take a daily supplement that
contains fat soluble vitamins and beta-carotene.
Hoffmann-La Roche Inc. is a leading
research-intensive pharmaceutical company that discovers, develops,
manufactures and markets numerous important prescription drugs that
improve, prolong and save the lives of patients with serious
illnesses. The company provides a wide range of medications in the
United States through its marketing and sales subsidiary, Roche
Laboratories Inc.
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