The FDA has granted accelerated approval to Ultomiris (ravulizumab) to reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk for disease progression, making it the first and only C5 complement inhibitor approved for this use.
The approval followed Priority Review and was based on a prespecified interim analysis of the I CAN phase 3 trial, according to an Oct. 21 news release. Ultomiris demonstrated a 43.4% reduction in proteinuria compared with placebo at 34 weeks.
Ultomiris is administered intravenously every eight weeks in adults, based on body weight, following a loading dose. The trial’s safety profile was consistent with the known profile of Ultomiris, with no new safety concerns identified.
The accelerated approval is based on reduction of proteinuria. It has not been established whether Ultomiris slows kidney function decline in patients with IgA nephropathy. Continued approval may depend on verification of clinical benefit in the ongoing I CAN trial.
The trial was designed to enroll approximately 510 participants from 28 countries. Its final analysis will assess change in estimated glomerular filtration rate at week 106, with data intended to support traditional FDA approval.
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