AstraZeneca: FDA Issues CRL Regarding SBLA Of Ultomiris In NMOSD

(RTTNews) - AstraZeneca PLC (AZN.L, AZN) said the FDA has issued a complete response letter regarding the supplemental Biologics License Application for long-acting C5 complement inhibitor Ultomiris for the treatment of adult patients with neuromyelitis optica spectrum disorder who are anti-aquaporin-4 antibody positive. The company said FDA requested modifications to enhance the Ultomiris Risk Evaluation and Mitigation Strategy to further validate patients' meningococcal vaccination status or prophylactic administration of antibiotics prior to treatment.

AstraZeneca stated that the CRL did not request additional analysis or reanalysis of the trial data and did not raise concerns about the efficacy or safety data.

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