Posted by Michael Wonder on 06 Sep 2023
Update on US regulatory review of Ultomiris in NMOSD
6 September 2023 - The US FDA has issued a complete response letter regarding the supplemental biologics license application for long-acting C5 complement inhibitor Ultomiris (ravulizumab-cwvz) for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 antibody positive.
The complete response letter did not request additional analysis or reanalysis of the Phase III CHAMPION-NMOSD trial data included in the submission and did not raise concerns about the efficacy or safety data from the trial.
