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La Jolla reactivates Phase III Riquent trial

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

La Jolla has reactivated enrollment in a Phase III trial of Riquent (abetimus sodium) in lupus renal disease under a special protocol assessment. The trial is being conducted at FDA's request based on clinical deficiencies relating to the firm's previous Phase II and Phase III trials cited in an October 2004 "approvable" letter (1Pharmaceutical Approvals Monthly November 2004, p. 13). FDA recommended another study to distinguish Riquent from placebo through an endpoint such as time to renal flare. La Jolla plans to enroll 600 patients by the second half of 2007 and has expanded the trial to include Europe and Mexico...

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