The FDA approved Ultomiris for the treatment of adults with anti-aquaporin-4 antibody-positive neuromyelitis optica spectrum disorder, according to a press release from Alexion.
The approval was based on positive results from the phase 3 CHAMPION-NMOSD trial that compared Ultomiris (ravulizumab-cwvz), a long-acting C5 complement inhibitor, with an external placebo arm from the pivotal Soliris (eculizumab) PREVENT clinical trial.
The primary endpoint was time to first on-trial relapse as confirmed by an independent adjudication committee. There were no relapses observed in patients on Ultomiris