US FDA panel split on Genelab's Aslera

The US Food and Drug Administration's Arthritis Advisory Committeehas failed to agree whether trials of Genelabs and Watson Pharmaceuticals' Aslera (prasterone), a synthetic version of the hormone dehydroepiandrosterone for treating systemic lupus erythematosus, showed enough benefit to recommend putting the drug on the market. Aslera was developed with the aim of controlling patients' disease and decreasing their need for steroids and, if approved, may become the first drug in decades for the treatment of this chronic disease.

Statisticians on the FDA advisory committee said that Genelab's study had too many shortcomings. However, physicians have said that SLE patients are desperate for new options, and it is possible that the drug might help some people, according to Reuters. FDA panellist Gary Firestein of the University of California said that "there might be some marginal or modest benefit, and that is important in an area where there have not been any drugs approved in a long time," but Janet Elashoff at Cedars-Sinai Medical Center said she felt "very uncomfortable" concluding that Aslera worked no better than a placebo.