Shots:
- The US FDA has received the BLA seeking accelerated approval of atacicept for treating adults with immunoglobulin A nephropathy (IgAN), with the FDA’s decision expected in 2026
- The BLA is supported by the ongoing global P-III (ORIGIN 3) trial evaluating atacicept (150mg, SC, QW) vs PBO in 431 adults with IgAN, assessing eGFR-based kidney function over 2yrs., with completion expected in 2027
- Trial met its 1EP, with 46% reduction in proteinuria at 36wks. & demonstrated 42% decrease in UPCR & favorable safety; results were presented at ASN Kidney Week’25 & published in The NEJM
Ref: Vera Therapeutics | Image: Vera Therapeutics | Press Release
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