FDA Grants Accelerated Approval for Ravulizumab in IgA Nephropathy

The FDA has granted accelerated approval to ravulizumab-cwvz (Ultomiris) for reducing proteinuria in adults with primary IgA nephropathy who are at risk of disease progression. This marks the first C5 complement inhibitor approved for this specific use and its fifth overall indication. Continued approval is contingent on confirming clinical benefit in an ongoing trial, highlighting the need for further data to solidify its long-term efficacy.