BASEL (dpa-AFX) - The U.S. FDA on Wednesday approved AstraZeneca (AZN) subsidiary Alexion's Ultomiris to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression.
The accelerated approval makes Ultomiris, or ravulizumab, the first and only C5 complement inhibitor approved for this use. Novartis' Fabhalta, or iptacopan, is also approved for this indication but targets complement factor B.
The decision followed Priority Review and was based on a prespecified interim analysis of the Phase III I CAN trial. At week 34, Ultomiris reduced urine protein levels by 46.6% from baseline, compared with 5.6% for placebo, yielding a placebo-adjusted reduction of 43.4%.
Its safety profile was consistent with previous findings, with no new safety concerns identified.
The company noted that it has not been established whether Ultomiris slows kidney function decline in IgAN. Continued approval may depend on confirmation of clinical benefit in the ongoing trial, which will assess kidney function at week 106.
Ultomiris is administered intravenously every eight weeks in adults following a loading dose. The approval marks its fifth indication.
Regulatory submissions are also under review in Japan and other countries. Late-breaking trial results will be presented at the American Society of Nephrology's Kidney Week on October 23.
AZN closed at $168.45, down 0.22%.
In the overnight trading, shares fell 0.21% to $168.10.
Copyright(c) 2026 RTTNews.com. All Rights Reserved
Copyright RTT News/dpa-AFX
© 2026 AFX News
