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Watson/Genelabs Prestara "approvable"

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Genelabs will conduct six-month clinical trial to confirm a positive effect for Prestara (prasterone, formerly Aslera) with bone mineral density as the primary endpoint, following an Aug. 28 "approvable" letter. Genelabs' study GL95-02 showed an effect on bone mineral density in 381 women with mild to moderate systemic lupus erythematosus; the other pivotal trial used steroid reduction as the endpoint. FDA's Arthritis Advisory Committee had expressed concern about prasterone's failure to reach prospectively defined primary endpoints at its April 19, 2001 meeting, and FDA issued a "not approvable" letter June 26, 2001. Additional analyses from GL95-02 were submitted in February 2002, showing significant increases in lumbar spine and hip bone mineral densit

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