Otsuka’s Voyxact raises the bar in IgA nephropathy

IgA nephropathy has become a case study in how validating a surrogate endpoint can catalyze drug development. Now, Phase III data from Otsuka’s Voyxact suggest the resulting competition is raising the bar: the anti-APRIL antibody is the first therapy to reduce the average loss of kidney function to zero.

In the Phase III VISIONARY study, anti-APRIL mAb Voyxact sibeprenlimab from Otsuka Holdings Co. Ltd. (Tokyo:4578) produced an annualized total eGFR slope of 0.3 mL/min/1.73 m² over two years, indicating that kidney function was stable on average, compared with a decline of 4.8 mL/min/1.73 m² in the placebo group...