FDA Approves Avandia (Rosiglitazone) In Combo Therapy For Type 2 Diabetes

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FDA Approves Avandia (Rosiglitazone) In Combo Therapy For Type 2 Diabetes

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PHILADELPHIA, PA -- April 4, 2000 -- Kline Beecham announced that the

United States Food and Drug Administration (FDA) has approved the company's oral

anti-diabetes agent Avandia® (rosiglitazone maleate) for use as a type 2

diabetes treatment in combination with drugs of the sulfonylurea class as an

adjunct to diet and exercise. Avandia, approved for treating type 2 diabetes as

both monotherapy and in combination with metformin, is one of a novel class of

oral anti-diabetes agents, commonly called glitazones, which treat the symptoms

of type 2 diabetes by directly targeting insulin resistance-an underlying cause

of the disease.

Many type 2 diabetes patients are prescribed sulfonylureas as first-line

therapy. However, these older anti-diabetes drugs do not treat insulin

resistance and over time may eventually lose effectiveness. Avandia, when added

to sulfonylurea therapy, enhances the blood-sugar lowering effect of the

sulfonylureas and targets insulin resistance. The combination of Avandia and

sulfonylureas may deliver a more powerful assault on the symptoms of type 2

diabetes over time in patients inadequately controlled on sulfonylureas alone.

" We are pleased that the FDA has approved Avandia for use in combination with

sulfonylureas, " said Brand, Vice President Cardiovascular/Endocrine

Business Units at Kline Beecham. " Increasing prescriptions and new

indications for Avandia offer evidence of continued confidence in its efficacy

and safety profile, which to-date remains consistent with its extensive clinical

trial experience. "

A valuable component of the type 2 diabetes treatment regimen, Avandia leads the

glitazone class in market share. More patients have been started on Avandia than

on any other glitazone.

In patients inadequately controlled on sulfonylureas alone, the safety and

efficacy of Avandia was evaluated in combination with sulfonylureas. In three

randomized, double-blind, 6-month studies, both fasting plasma glucose (FPG) and

glycosylated hemoglobin (HbA1c), two important blood-sugar measures, were

significantly improved in patients given Avandia plus sulfonylureas as compared

to those given sulfonylureas alone. Further, open label extension trials

demonstrated sustained effectiveness of Avandia and sulfonylureas over an

additional nine-month period. The combination therapy produced and maintained

impressive reductions in FPG and HbA1c throughout the duration of the trials.

The addition of Avandia to sulfonylureas resulted in significant improvements in

insulin sensitivity and estimates of beta-cell function as compared to baseline.

" Avandia enhances improvement of blood-sugar control for patients when added to

sulfonylureas, " said Krause, M.D., Vice President and Director, Clinical

Research, Development and Medical Affairs at Kline Beecham. " Reducing

blood-sugar levels and targeting insulin resistance, Avandia in combination with

sulfonylureas should provide significantly better control of type 2 diabetes

than sulfonylureas alone, consistent with an additive effect. "

Diabetes, which is the sixth highest cause of death by disease in the United

States, strikes an estimated 16 million Americans -- 90 to 95 percent of whom

have type 2 diabetes. Type 2 diabetes is one of the most costly health problems

in America due to its devastating complications. It is the leading cause of

adult blindness, kidney failure and non-traumatic limb loss in the U.S. Diabetes

is a chronic disease characterized by high blood-sugar levels that result from

defects in the body's ability to use and/or produce insulin. Many patients with

type 2 diabetes will eventually require insulin injections.

On May 25, 1999, Avandia received approval from the FDA for the treatment of

type 2 diabetes as both monotherapy and in combination with metformin as an

adjunct to diet and exercise. The FDA approval was based on a review of data

from clinical studies involving more than 4,500 patients with type 2 diabetes in

which Avandia was proven to be safe and effective.

Avandia was generally well tolerated in clinical trials. Commonly reported

adverse events were upper respiratory tract infections and headaches. Patients

receiving Avandia in combination with sulfonylureas may be at risk for

hypoglycemia and a reduction in the sulfonylurea dose may be necessary. As

observed with other members of this glitazone class of drugs, improvements in

glycemic control were associated with weight gain. Additionally, a low incidence

of anemia and edema were reported. Overall, the types of adverse experiences

reported when Avandia was used in combination with sulfonylureas were similar to

those during monotherapy with Avandia.

Kline Beecham -- one of the world's leading healthcare companies --

discovers, develops, manufactures and markets pharmaceuticals, vaccines,

over-the-counter medicines and health-related consumer products.