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Genelabs Prestara update

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Genelabs plans to meet with FDA "to discuss the company's options with regard to the development of Prestara [prasterone] for lupus," the firm says June 22. Future development of Prestara also hinges on the outcome of an open-label extension study of a failed confirmatory trial looking at the agent's effect on bone mineral density. The trial is slated to complete in August 2005. "While [the study] may provide useful data on the effect of Prestara on bone mineral density of women with lupus over a longer period of time, the FDA normally does not consider such open-label studies to be sufficient to support approval of a new drug," Genelabs noted. La Jolla is currently conducting a confirmatory trial for its lupus agent Riquent (abetimus) (1Pharmaceutical Approvals Monthly November 2004, p. 13); Immunomedics' monoclonal antibody epratuzumab recently entered Phase III for the autoimmune disease...

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