AstraZeneca Reports FDA’s sBLA Acceptance Under Priority Review for Ultomiristo Treat IgA Nephropathy

Shots: The US FDA has accepted sBLA & granted priority review to AZ's Ultomiris (ravulizumab) for the treatment of adults with immunoglobulin A nephropathy (IgAN), with a PDUFA action date anticipated in Q4’26 sBLA was supported by the interim analysis data from the global P-III (I CAN/ALXN1210-IgAN-320) trial assessing Ultomiris (IV) vs PBO in ~510 adults with…

ByRidhi RastogiJune 15, 2026

AstraZeneca Reports the P-III (I CAN) Trial Data on Ultomiris for IgA Nephropathy

Shots: AstraZeneca has reported the global P-III (I CAN/ALXN1210-IgAN-320) trial assessing Ultomiris (IV) vs PBO in ~510 adults with IgAN who are at risk of disease progression Trial showed a 46.6% reduction in 24-hr. UPCR from baseline at 34wks. vs 5.6% with PBO, as early as Wk. 10 & sustained through 34wks. The results were consistent…

ByRidhi RastogiJune 8, 2026

Otsuka Pharmaceutical Reports P-III (VISIONARY) Trial Data on Voyxact for IgA Nephropathy (IgAN)

Shots: Otsuka reported the ongoing P-III (VISIONARY) trial data assessing Voyxact (sibeprenlimab; n= 320) vs PBO (n=152) in preserving kidney function in IgAN pts over a 24mos. treatment period At 12mos., Voyxactimproved kidney function with a mean eGFR change from baseline of +0.7 vs -4.8 mL/min/1.73 m², achieving the KDIGO treatment goal of limiting annual kidney…

ByRidhi RastogiJune 5, 2026

AstraZeneca Reports FDA’s sBLA Acceptance Under Priority Review for Ultomiristo Treat IgA Nephropathy

AstraZeneca Reports the P-III (I CAN) Trial Data on Ultomiris for IgA Nephropathy

Otsuka Pharmaceutical Reports P-III (VISIONARY) Trial Data on Voyxact for IgA Nephropathy (IgAN)

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