(News Bulletin 247) – AstraZeneca advises that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to the Supplemental Biologics License Application (sBLA) that was requested for Ultomiris (ravulizumab-cwvz) for the treatment of adult patients with neuromyelitis optica spectrum (NMOSD) positive for anti-aquaporin-4 (AQP4) (Ab+) antibodies.
The FDA did not request additional analysis or reanalysis of the Phase III trial data included in the sBLA application and did not raise any concerns about the efficacy or safety data from the trial.
Instead, the FDA requested changes to improve the REMS (Risk Assessment and Mitigation Strategy) of Ultomiris to further validate the meningococcal vaccine status of patients or the prophylactic administration of Ultomiris. antibiotics before treatment.
Alexion, AstraZeneca’s rare disease division, is working closely with the FDA regarding the next steps for REMS changes and remains committed to bringing Ultomiris to people living with NMOSD in the United States as soon as possible.
Copyright (c) 2023 News Bulletin 247. All rights reserved.
I have over 8 years of experience working in the news industry. I have worked as a reporter, editor, and now managing editor at 247 News Agency. I am responsible for the day-to-day operations of the news website and overseeing all of the content that is published. I also write a column for the website, covering mostly market news.
