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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Business News
April 17, 2026 15:29 ET The ongoing conflict in the Middle East continues to raise concerns for policymakers who worry about the impact of the supply shock and high energy prices on the real economy. Producer price data and various survey results on the housing market were the main news from the U.S. this week. In Europe, industrial production data for the euro area gained attention. GDP figures out of China and the policy move by the Singapore central bank were in focus in Asia.