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news.The FDA has approved a phase III trial design from Genelabs Technologies which will assess Prestara in the treatment of lupus.
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The agency has also indicated to Genelabs that a positive outcome to the proposed new phase III study in addition to evidence of efficacy from previous trials of Prestara would in principle meet FDA standards for a new drug application approval.
The primary endpoint for this phase III trial will be time to first severe lupus flare. The principal secondary endpoint will be time to first treatment intervention for moderate or severe lupus flare. The study will target enrollment of approximately 500 women with active systemic lupus erythematosus who are receiving standard of care medications such as glucocorticoids, cytotoxic and immunosuppressive agents.