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Drug Review Europe Regulation

New EU Filings

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Executive Summary

Elafibranor, Ipsen/Genfit’s investigational oral, once-daily drug for primary biliary cholangitis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

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Orphan Drugs Dominate Latest EU Filings

Sotatercept, marstacimab, elafibranor, eplontersen, mirvetuximab soravtansine, troriluzole and tiratricol are among the latest products that the European Medicines Agency has started reviewing for potential EU marketing approval.

Treatment For Maple Syrup Urine Disease Among 10 New EU Filings

REC 0545, for MSUD, and aztreonam-avibactam, for serious Gram-negative bacterial infections, are among the latest drugs that the European Medicines Agency has started reviewing for potential pan-EU marketing approval.

Products Targeting Alzheimer's, Duchenne & COVID-19 Among New EU Filings

EU marketing authorization applications have been submitted for a number of new drugs, including Eli Lilly’s donanemab, Italfarmaco's givinostat and Arcturus Therapeutics/CSL’s ARCT-154.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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