Special protocol assessment for HGS/GSK LymphoStat-B
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA grants an SPA for Phase III trials of LymphoStat-B (belimumab) in active systemic lupus erythematosus, Human Genome Sciences announces Oct. 26. The pivotal program, expected to start by year-end, will include two superiority trials, the 52-week BLISS-52 and 76-week BLISS-76 studies, each to enroll 810 patients with serologically active SLE. The SPA accepts a combined patient response rate endpoint that "emerged directly" from GSK and HGS' analysis of a Phase II study that failed to show clinical benefit at week 24 (1Pharmaceutical Approvals Monthly August 2006, p. 32)...