Genelabs Prestara update
This article was originally published in Pharmaceutical Approvals Monthly
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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