Avandia approved in USA as competitor to Rezulin in diabetes market

SmithKline Beecham's new glitazone drug for the management of type 2diabetes, Avandia (rosiglitazone maleate) was approved for marketing by the US Food and Drug Administration on May 25, and becomes the first competitor to Warner-Lambert's Rezulin (troglitazone) in the thiazolidinedione class of insulin sensitizers. The drug is indicated for use both as a monotherapy and in combination with Bristol-Myers Squibb's Glucophage (metformin), and will be made available "in the next few days," according to the company.

Avandia recently received marketing approval in its first market, Mexico, and has also been filed for regulatory clearance with the European Medicines Evaluation Agency and in 13 other markets worldwide. Launch of the product in the USA and Mexico will occur at around the same time, said a spokesman for the firm, who added that a launch in a major European market is expected before the end of the year.

The wholesale price for the drug in the USA will be $1.45 for a 2mg tablet, $2.00 for a 4mg tablet and $3.65 for 8mg. As expected, Avandia was approved for both once-daily (1 x 4mg) and twice-daily (2 x 2mg) use, with an option to raise the dose to 8mg if necessary (8mg is expected to be optimal for many patients). This pricing is a discount of approximately 10%-15% compared to Rezulin, according to analysts.