La Jolla Hopes Parallel Riquent Antibody Study Can Be “Arm” In Ongoing Trial

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.