But physicians said the drug might help some people and that patients are desperate for new options. Researchers acknowledged several changes during the studies, including adjusting parts of the analysis to include only patients with more severe disease. The committee did not vote on whether to recommend FDA approval for Aslera. About 200,000 U.S. patients, about 90 percent of them women, are diagnosed each year with lupus. The disease causes the immune system to attack the body's own tissues, leading to fatigue, arthritis, organ damage and other problems that can range from mild to life-threatening.
Current treatments provide limited relief.
Steroids often are prescribed, but they can cause serious damage over time. Aslera was developed with the goal of controlling patients' disease and decreasing their need for steroids. Dietary supplements containing DHEA are sold in health food stores, and patients and physicians said people with lupus have been taking it. Genelabs, based in Redwood City, Calif., is hoping Aslera will be its first product cleared for marketing in the United States. Calif.-based Watson is looking to branded products to expand its portfolio beyond generic medicines.