FDA panel grapples with DHEA

Members of an FDA advisory committee on Thursday said that data presented by Genelabs (GNLB) on the use of Aslera prasterone DHEA ( GL701) to treat women with systemic lupus erythematosus (SLE) does not meet the FDA's traditional standards for demonstrating efficacy and safety. Several panel members, however, said they think the product has some efficacy, presents little risk, and if it were approved they would prescribe it for patients.

FDA asked the Arthritis Advisory Committee to discuss a number of issues, but the agency did not request votes on any questions. FDA officials expressed a number of concerns about GNLB's data, noting that the company's two Phase III trials failed to achieve statistically significant results for their pre-defined primary endpoints. FDA officials also suggested that many of the issues with GNLB's data reflected the difficulties inherent in studying SLE, a rare disease that is poorly understood. ...