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|Prestara™ and Lupus
|Prestara™ (known in development as GL701)
is being developed by Genelabs as an investigational new drug for women
with systemic lupus erythematosus (SLE or lupus), a chronic autoimmune
disease for which no new drug has been approved in the U.S. in more than
40 years. Prior to Genelabs' work in this area, there had been no large,
well-controlled clinical trials for assessing the safety and efficacy of
new drugs for this disease. Working together with internationally
recognized lupus experts, Genelabs designed and conducted pioneering
clinical trials using Prestara as an investigational drug for women with
SLE. These efforts resulted in the submission of a new drug application
(NDA) to the Food and Drug Administration (FDA).
Lupus affects primarily women, who generally are diagnosed while of childbearing age, and can cause significant morbidity and disruption of daily activities. Lupus is characterized by alternating periods of active disease symptoms (flares) and periods of quiescence. Inflammation occurs in all patients, and symptoms can include irreversible damage to almost every organ and organ system, including the musculoskeletal, renal, pulmonary, neurological, cardiovascular, and cutaneous systems, as well as depression and severe fatigue, all of which can reduce their health-related quality of life.
Glucocorticoids, one of the mainstays of current SLE therapy, are often used to treat lupus. However, glucocorticoids often produce significant side effects including bone loss, infection, accelerated atherosclerosis, significant weight gain and other long-term complications. Other drugs commonly used to treat lupus include anti-malarials, immunosuppressives, and non-steroidal anti-inflammatory agents.