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Europe Drug Review Regulation

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

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Executive Summary

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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New EU Filings

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.

New EU Filings

Imetelstat, Geron’s investigational treatment for transfusion-dependent anemia in patients with lower-risk myelodysplastic syndromes, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

New EU Filings

Givinostat, Italfarmaco’s investigational treatment for Duchenne muscular dystrophy, 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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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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