Avandia

The largest diabetes-prevention study ever done has found that a drug already used to treat the disease can also help keep "pre- diabetics" from developing it. But many experts said losing weight and exercising remain a safer, cheaper approach. The drug, rosiglitazone, or Avandia, appeared to cut the risk of developing Type 2 diabetes by more than half, doctors reported yesterday. Type 2 is the most common form of diabetes, afflicting more than 200 million people worldwide.

Data presented at the 53rd Annual Scientific Session of the American College of Cardiology (ACC) demonstrated that the insulin sensitizer Avandia (rosiglitazone maleate) may have certain cardiovascular benefits for patients with type 2 diabetes:

DRUGS giant GlaxoSmithKline is facing legal action in the US over claims that it failed to warn patients its high-selling insulin drug Avandia could cause heart and liver failure. The product liability suit was brought on behalf of 24 Californian and eight Texan diabetes patients, some of whom claim they needed liver transplants just weeks after starting the drug.

The FDA has decided not to pursue any labeling change or additional warnings for SmithKline Beecham's diabetes treatment Avandia (rosiglitazone), despite reports of liver injury associated with the drug.

Diabetics are getting a long-awaited new treatment that promises to help control their disease with less risk and a cheaper price tag than a popular but sometimes dangerous drug. SmithKline Beecham Pharmaceuticals said Avandia, approved for sale by the Food and Drug Administration, will reach pharmacy shelves within a few days.

Diabetics frightened by reports a popular treatment may destroy some patients' livers may soon get a new choice: Government advisers recommended Thursday the approval of Avandia, a drug that promises to fight diabetes with fewer liver risks. No one can say for certain that Avandia never will damage diabetics' livers, advisers to the Food and Drug Administration said. Indeed, they urged Avandia patients to have intensive liver testing similar to the kind now required for patients who take the controversial competing drug Rezulin.

SmithKline Beecham (NYSE: SBH) announced today that the United States Food And Drug Administration (FDA) has granted six-month priority review to Avandia(TM) (rosiglitazone maleate), the company's investigational compound for the treatment of type 2 diabetes mellitus. The FDA grants priority review to drugs that, if approved, would be a significant improvement compared to marketed products. SmithKline Beecham submitted its new drug application for Avandia in November.

SmithKline Beecham (NYSE: SBH) (SB) announced today that it has submitted to the U.S. Food and Drug Administration (FDA) a New Drug Application (NDA) to market Avandia(TM) (rosiglitazone maleate), an investigational drug which has been studied to date in over 4,000 patients for the treatment of type 2 diabetes (either as monotherapy or in combination with other drugs). The file was submitted ahead of the Company's target date. Avandia directly targets insulin resistance -- an underlying condition responsible for type 2 diabetes -- and is a member of a new class of oral insulin sensitivity enhancers...