La Jolla Hopes Parallel Riquent Antibody Study Can Be “Arm” In Ongoing Trial
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA’s Oct. 14 “approvable” letter requests additional Riquent dose-response data on antibodies to double-stranded DNA; data could be used to validate dsDNA as surrogate marker. La Jolla has sought accelerated approval for the lupus therapy based on the biomarker; ongoing trial is designed to confirm clinical benefit in renal disease.
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