The FDA Issued A Complete Response Letter Regarding AstraZeneca's Supplemental Biologics License Application For Ultomiris (Ravulizumab-cwvz) For Neuromyelitis Optica Spectrum Disorder Patients Who Are Anti-aquaporin-4 Antibody Positive
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The FDA has issued a Complete Response Letter (CRL) to AstraZeneca regarding its Supplemental Biologics License Application for Ultomiris (Ravulizumab-cwvz) for Neuromyelitis Optica Spectrum Disorder patients. The FDA did not request additional analysis of the Phase 3 trial data and did not raise concerns about the efficacy or safety data. However, it requested modifications to enhance the Ultomiris Risk Evaluation and Mitigation Strategy.
September 06, 2023 | 8:24 am
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NEUTRAL IMPACT
AstraZeneca received a Complete Response Letter from the FDA for Ultomiris, requesting modifications to the Risk Evaluation and Mitigation Strategy. No concerns were raised about the trial data.
The FDA's request for modifications to the Risk Evaluation and Mitigation Strategy for Ultomiris could delay its approval, potentially impacting AstraZeneca's stock in the short term. However, the lack of concerns about the trial data is a positive sign.
CONFIDENCE 90
IMPORTANCE 75
RELEVANCE 100
NEUTRAL IMPACT
AstraZeneca received a Complete Response Letter from the FDA for Ultomiris, requesting modifications to the Risk Evaluation and Mitigation Strategy. No concerns were raised about the trial data.
The FDA's request for modifications to the Risk Evaluation and Mitigation Strategy for Ultomiris could delay its approval, potentially impacting AstraZeneca's stock in the short term. However, the lack of concerns about the trial data is a positive sign.
CONFIDENCE 90
IMPORTANCE 75
RELEVANCE 100