SmithKline Beecham has reported that it has received Food and Drug Administration approval to market Avandia, a diabetes drug that is expected to bring competition to the controversial Rezulin.
The FDA approved Avandia (rosiglitazone) on May 25 for the treatment of type 2 diabetes as both monotherapy and in combination with metformin. "Most older type 2 diabetes medicines work by increasing insulin production in the pancreas or decreasing glucose output through the liver, whereas Avandia sensitizes the body to use its own natural insulin more effectively," SmithKline Beecham said in a statement.
The approval was based on data from clinical studies involving more than 5,500 patients with type 2 diabetes. In the studies, Avandia lowered blood sugar levels of patients by up to an average of 76 mg/dl, compared to placebo, and maintained blood sugar control for up to a year. There were no reported cases of drug-related jaundice or liver failure.
Avandia is expected to compete with Warner-Lambert's Rezulin (troglitazone), which also attacks the underlying causes of diabetes. Rezulin has been associated with acute liver failure in at least 38 patients, including 28 who died and another seven who needed liver transplants. In March, an FDA advisory committee recommended that Rezulin could stay on the market (see Transplant News Network, April 1, 1999).
In other news, Pfizer Inc. said that its quinolone antibiotic Trovan has been associated with "very rare cases of serious, severe and unpredictable liver injury." According to Reuters news service, the European Union Agency for the Evaluation of Medicinal Products said Trovan has been associated with 140 documented cases of serious liver injuries. Eight patients died or required a liver transplant since the drug was introduced in the United States in February 1998. Pfizer said the company is working on label revisions.
Please be aware that medical advice, diagnoses and physician references cannot be obtained from this site.