La Jolla Riquent SPA
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
La Jolla initiates a Phase IV trial of its pending lupus agent Riquent (abetimus) to support full approval, the firm announces Aug. 2. The randomized, double-blind, placebo-controlled study was agreed to under the special protocol assessment process and will meet FDA's accelerated approval requirement for a confirmatory postmarketing study. La Jolla said the trial design has "several enhancements" compared to prior Riquent studies, "including twice as many patients receiving Riquent compared with placebo, increased patient enrollment of approximately 500 to 600 patients, more control of immunosuppressive drugs at baseline, higher doses of Riquent in some treatment groups, and 12-month treatment duration for each patient." The primary endpoint is time to renal flare. The study will continue for "several years." Riquent's PDUFA date is Oct. 16 (1Pharmaceutical Approvals Monthly Jan 1, 2004, p. 15)...