Prestara fails confirmatory trial
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Genelabs plans to meet with FDA to "determine the next steps" for Prestara (prasterone) after the lupus therapy fails to show a positive effect on bone mineral density in a confirmatory Phase III trial, the firm says Oct. 5. The trial, requested by FDA in an August 2002 "approvable" letter, found that Prestara did not increase lumbar spine BMD. Genelabs said that if a plan is reached with FDA to continue with Prestara, the product's indication could be narrowed to target treatment of lupus by limiting bone loss in women on glucocorticoids. The company's initial proposed indication is "treatment of women with systemic lupus erythematosus." Genelabs has had several setbacks with prasterone - the latest being the withdrawal of its European submission in June 2004 (1Pharmaceutical Approvals Monthly June 1, 2004, p. 17)...