Otsuka to take advantage of newly charted accelerated pathway for IgA nephropathy

An interim readout from a Phase III study may suffice for Otsuka to obtain FDA approval of sibeprenlimab, setting up the anti-APRIL antibody as a possible first-in-class entrant in IgA nephropathy.

Otsuka Holdings Co. Ltd. (Tokyo:4578) said Tuesday that an interim analysis showed sibeprenlimab met the study’s primary endpoint of proteinuria, which has previously served as a surrogate endpoint supporting accelerated approval of other treatments for IgA nephropathy. The pharma did not release detailed data on the outcome, which measured 24-hour urine protein-to-creatine ratio at nine months compared with placebo...