Xenical: Type 2 Diabetes indication filed in the US
Roche announced today that a supplemental New Drug Application
(sNDA) has been submitted to the US Food and Drug Administration
(FDA) for Xenical (orlistat), as an adjunct to other anti-diabetic
medications for the treatment of type 2 diabetes in patients
who are overweight or obese. Approval of this indication would
provide an additional market opportunity for Xenical in the
US, where it is already approved for weight management in patients
who are overweight or obese.
Xenical is a unique weight management treatment that acts
locally by preventing fat being absorbed in the gut. Xenical
not only helps patients lose weight, it also encourages more
healthy eating habits, so helping them maintain their weight
Clinical studies with Xenical in diabetes have shown:
overweight and obese patients with type 2 diabetes taking
Xenical lost up to three times more weight than those on diet
Xenical patients had clinically significant improvements
in blood sugar control
more patients treated with Xenical were able to reduce the
dose of, or even discontinue their anti-diabetic medications
additional data have also shown that Xenical can improve
certain risk factors for cardiovascular disease, such as total
cholesterol levels and blood pressure in diabetic patients.
Type 2 diabetes is a major global public health problem with
the incidence and prevalence of diabetes escalating towards
a world-wide epidemic. In the USA the prevalence of type 2
diabetes increased by one-third between 1990 and 1998. Many
other countries report a similar experience and it has been
estimated that, on a global level, almost 300 million people
could have type 2 diabetes by the year 2025. The major underlying
cause of this diabetes epidemic is the increasing prevalence
of obesity. Almost 90 per cent of patients with type 2 diabetes
are overweight or obese. Weight is the most important modifiable
risk factor in patients with type 2 diabetes. Type 2 diabetes
is associated with a high risk of several complications that
may lead to premature cardiovascular morbidity and mortality.
Weight management is the first-line treatment of type 2 diabetes.
Even a modest reduction of initial body weight improves blood
sugar control in patients with type 2 diabetes and also reduces
the severity of cardiovascular risk factors such as high cholesterol
levels and high blood pressure.
Xenical is a breakthrough in weight management treatment
and is the most extensively studied pharmacological weight
management treatment to date , with over 30,000 overweight
or obese patients participating in clinical trials with Xenical.
Over 2,500 patients with type 2 diabetes have been involved
in Xenical clinical trials. It is an effective therapy which
not only helps patients lose weight, but also helps them maintain
their weight loss. It is the only available weight loss medication
that works locally in the gut to prevent dietary fat absorption
by about 30 percent. Xenical is well tolerated and unlike
other weight loss medications it does not act on the central
nervous system. In clinical trials, non-diabetic people taking
Xenical in conjunction with a mildly reduced calorie diet
have shown twice as much weight loss as diet alone. Since
it was first marketed in 1998, there have been more than 8.5
million patient treatments with Xenical world-wide. Xenical
is licensed for weight management in patients who are overweight
or obese in over 100 countries around the world.
Headquartered in Basel, Switzerland, in Roche is one of the
world’s leading research-oriented healthcare groups in the
fields of pharmaceuticals, diagnostics and vitamins. Roche’s
innovative products and services address prevention, diagnosis
and treatment of diseases, thus enhancing people’s well being
and quality of life.