Type-2-Diabetes: FDA extends
exclusivity of Glucophage for use in pediatric patients in the
United States
Darmstadt/Germany, and Princeton, N.J./USA,
23 March 2000 - Merck KGaA announced today that Bristol-Myers
Squibb, its U.S. licensee for Glucophage (metformin), has been
granted an extension on the marketing exclusivity of Glucophage
through September 3, 2000 by the U.S. Food and Drug Administration
(FDA). Glucophage, the world's leading Type-2-Diabetes therapy,
is a registered trademark of Lipha S.A., the Ethicals business
of the Merck Group in France, and is licensed to Bristol Myers
Squibb in the United States. Global sales of Glucophage increased
by +53 percent to EUR 1,393 million in 1999, of which USD 1.312
million have been generated in the United States.
Bristol-Myers Squibb received a six-month
extension on the exclusivity of Glucophage after complying
with a written request from the FDA to perform clinical studies
to assess the safety, efficacy and pharmacokinetic profile
of Glucophage in pediatric populations. Based on the results
of these clinical studies, Bristol-Myers Squibb has filed
a supplemental New Drug Application (sNDA) to gain FDA clearance
of Glucophage for use in pediatric patients (ages 10-16) with
Type-2-diabetes. The sNDA is under review by the FDA.
As part of the FDA Modernization Act, the
U.S. Congress included provisions to encourage more investigation
of the unmet medical needs of pediatric patients. One provision
allows the Administration to request in writing that companies
voluntarily conduct clinical studies to evaluate the use of
their products in children. Companies that chose to comply
with the written request are granted an additional six-month
period of exclusivity following the submission of reports
on successfully completed pediatric studies that satisfy each
aspect of the FDA's request. In accordance with FDAMA, Bristol-Myers
Squibb conducted studies to determine the safety and efficacy
of Glucophage in pediatric patients with Type-2-diabetes.
Type-2-diabetes, a condition previously
thought to affect mostly adults over the age of 45, is now
being more frequently diagnosed in children. Physicians attribute
increases in Type-2-diabetes in children to environmental
factors such as poor diet and limited exercise. Hereditary
influences such as family history and ethnic background are
also associated with the increased incidence of the condition
in pediatric patients. Type-2-diabetes is a serious disease
that if left untreated and uncontrolled, can lead to complications
which may cause blindness, kidney failure and amputations.
On February 23, 2000, the American Diabetes Association (ADA)
recommended in a consensus statement that "If treatment
goals with nutrition, education, and exercise are not met,
pharmacologic therapy is indicated. The first oral agent used
should be metformin."
Bristol-Myers Squibb, as licensee of Merck
KGaA, continues to seek additional therapeutic alternatives
that offer new management options for patients with Type-2-diabetes.
In September 1999, the company announced that it had submitted
a New Drug Application (NDA) to the FDA for a novel product
that leverages and synergizes the benefits of metformin and
glybenclamide, a unique and proprietary formulation of a member
of a class of drugs known as sulfonylureas. Bristol-Myers Squibb
has also submitted an NDA for Glucophage XR Extended Release
Tablets, a once-daily version of Glucophage. Glucophage, as
an adjunct to diet and exercise, helps lower blood sugar by
decreasing hepatic glucose production, decreasing intestinal
absorption of glucose and improving insulin sensitivity.
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