The FDA has issued a complete response letter to AstraZeneca for its supplemental biologics license application of Ultomiris to treat adults with neuromyelitis optica spectrum disorder who are anti-aquaporin-4 antibody positive.
According to a release from AstraZeneca, the letter from the regulatory body is related to its request for modifications to enhance the Ultomiris (ravulizumab-cwvz) Risk Evaluation and Mitigation Strategy (REMS) to further validate patients’ meningococcal vaccination status or prophylactic administration of antibiotics prior to treatment.
The letter did not