FDA Sets Endpoint for Trials Testing Lupus Treatments

Drugmakers developing products for the treatment of systemic lupus erythematosus (SLE) should use a disease activity index such as the British Isles Lupus Assessment Group as the primary efficacy endpoint in clinical trials, the FDA says. Drugmakers also should conduct at least two adequate and well-controlled trials, the FDA says in a final guidance on developing drugs to treat SLE. The preferred design is a parallel, randomized, controlled superiority trial using placebo or active control. In general, the trial should be at least one year in duration.
Washington Drug Letter