Riquent Could Be Approved Based On Ongoing Confirmatory Study, La Jolla Says
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA’s “approvable” letter for lupus therapy Riquent cites need for additional study with endpoint of clinical benefit, such as time to renal flare. La Jolla had attempted to get accelerated approval using surrogate endpoint of change in antibodies to double-stranded DNA.