La Jolla Riquent doesn’t meet endpoint
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
La Jolla's lupus agent Riquent (formerly LJP 394) did not statistically significantly increase length of time to renal flare compared to placebo in a preliminary analysis of a 298-patient Phase III trial. Riquent appeared to be well tolerated; patients were treated up to 92 weeks (median of 46 weeks). The estimated median time to renal flare, the primary endpoint, was 123 months on the Riquent arm and 89 months on the placebo arm. Renal flares occurred in 17 (12%) Riquent patients and 24 (16%) placebo patients. "Changes in medical practice may have resulted in fewer renal flares because patients were being treated before a renal flare could have been observed or documented," La Jolla maintains. In a combined analysis of renal and/or major SLE flares, there were 33 (26%) events in Riquent patients and 51 (33%) in placebo patients. Riquent did yield a significant reduction in antibodies to double-stranded DNA, which is its intended pharmacologic effect. The company continues to analyze study result
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