BRIEF-AstraZeneca Says U.S. FDA Issues CRL For Ultomiris SBLA
- Country:
- United States
AstraZeneca PLC: * UPDATE ON US REVIEW OF ULTOMIRIS FOR NMOSD
* FDA ISSUED A CRL REGARDING SUPPLEMENTAL BIOLOGICS LICENSE APPLICATION (SBLA) FOR LONG-ACTING C5 COMPLEMENT INHIBITOR ULTOMIRIS * CRL DID NOT REQUEST ADDITIONAL ANALYSIS OR REANALYSIS OF PHASE III CHAMPION-NMOSD TRIAL DATA INCLUDED IN SBLA SUBMISSION
* CRL DID NOT RAISE CONCERNS ABOUT EFFICACY OR SAFETY DATA FROM TRIAL * FDA REQUESTED MODIFICATIONS TO ENHANCE ULTOMIRIS RISK EVALUATION AND MITIGATION STRATEGY (REMS) Source text for Eikon: Further company coverage:
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