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Europe Drug Review Regulation

Rozanolixizumab & Biosimilar Ustekinumab Among Raft Of New Drugs Filed In EU

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Executive Summary

The European Medicines Agency’s latest list of drugs under review for potential marketing approval includes a second generalized myasthenia gravis treatment from UCB and what could become the first biosimilar version of Stelara in the EU.

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New EU Filings

Seladelpar, CymaBay Therapeutics's investigational treatment 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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Acoramidis, AstraZeneca/BridgeBio Pharma's investigational treatment for patients with transthyretin amyloid cardiomyopathy, 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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Beremagene geperpavec, Krystal Biotech’s topical, redosable gene therapy for treating dystrophic epidermolysis bullosa, 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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