Shots:
Otsuka Pharmaceutical has reported P-III (VISIONARY) trial data evaluating Voyxact (sibeprenlimab-szsi; 400mg, SC, Q4W) vs PBO in IgAN pts at risk for disease progression
Trial showed 82.5% vs 52.6% pts achieved negative microscopic hematuria (0–5/HPF; exploratory EP) at 48wks., with a median time to achieve 0–5/HPF was 9 vs 24wks.; data were presented at…
Shots:
The US FDA has granted accelerated approval to Voyxact (sibeprenlimab-szsi) for the reduction of proteinuria in adults with primary IgAN at risk for disease progression
Approval was based on the interim data from the ongoing P-III (VISIONARY) trial, assessing Voyxact (400mg, SC, Q4W) vs PBO in 510 IgAN adults, who were on SoC therapy
Trial…

