Xenical for Obesity Filed for
Regulatory Applications
Dec. 2, 1996
Xenical:
Prices and Ordering Information
Roche Laboratories today
announced that it has filed a New Drug Application (NDA) with
the U.S. Food and Drug Administration (FDA) and a New Drug
Submission (NDS) to the Health Protection Branch (HPB) of
Canada to seek approval to market Xenical(R) for patients who
suffer from obesity. Xenical, a lipase inhibitor, is the first
of an entirely new pharmaceutical class of non-CNS,
non-systemic drug therapies for the treatment of
obesity.
"This regulatory filing is the
culmination of an intensive effort on the part of hundreds of
Roche employees and physicians throughout the world, all of
whom are working to improve the prognosis of patients who
suffer from this chronic, relapsing medical disease affecting
millions of Americans," said Patrick J. Zenner, President and
Chief Executive Officer. "We believe that Xenical will bring
enormous value to the obesity community and we will continue
to seek regulatory licensing throughout the world."
The multicenter,
placebo-controlled Phase III clinical trials involving nearly
5,000 obese patients studied the efficacy of Xenical when
taken in conjunction with a mildly hypocaloric diet containing
approximately one-third of all calories from fat. Xenical is
the only treatment to date to have been evaluated in two-year
clinical trials for weight loss, maintenance of lost weight,
prevention of weight regain and improvement in co-morbidities
including hypertension, dyslipidemia, impaired glucose
tolerance and hyperinsulinemia compared to diet
alone.
Xenical is an inhibitor of
gastric and pancreatic lipases -- enzymes that play a pivotal
role in the absorption of dietary fat. Experts agree that
excess caloric intake is a significant component in the
development of obesity, and for many people, excess dietary
fat is the largest component of this caloric excess. The
action of Xenical against lipases blocks the absorption of
approximately 30% of the fat eaten in food, which provides an
additional caloric deficit for weight loss and control. In
clinical trials, no major adverse side effects were noted. The
most common effects reported were non-systemic and were
primarily gastrointestinal, the majority of which were
generally mild and temporary and frequently seen among
patients who did not follow the appropriate diet
regimen.
In the U.S., more than 70 million
Americans are considered to be overweight and obese and are at
high risk for hypertension, cardiovascular disease,
non-insulin dependent diabetes, dyslipdemia, hyperinsulinemia
and hypercholesterolemia. As little as 5% reduction in
patients' weight improves their health outcomes
significantly.
Headquartered in Nutley, New
Jersey, Hoffmann-LaRoche 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 important prescription
pharmaceuticals.
The company's commitment to
metabolic research and development stems from its recognition
of obesity as a chronic disease needing long-term therapy. In
addition to Xenical, Roche, is pursuing investigation of the
OB receptor and is supporting gene therapy research through
its collaboration with the biotechnology company,
Millennium.