Genelabs Technologies, Inc, of Redwood City, California, announced that the US Food and Drug Administration will require an additional pivotal trial with robust demonstration of efficacy in order to approve Genelabs' Prestaraâ„¢ for either treatment of the signs and symptoms of systemic lupus erythematosus (SLE) or to prevent loss of bone mineral density in women with SLE.

Genelabs says that it has decided to pursue the indication for treating the signs and symptoms of SLE and is presently in the process of designing an additional trial for Prestara for the treatment of SLE. According to the company, if an additional trial is conducted it would likely be in conjunction with a collaborator, as Genelabs currently does not have sufficient funds to conduct the trial on its own.   

―A. Techman