Sanofi Receives EMA Orphan Designation For Efdoralprin Alfa

rttnews
2025.12.17 06:45
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Sanofi announced that the European Medicines Agency (EMA) has granted orphan designation to efdoralprin alfa, an investigational drug for treating alpha-1 antitrypsin deficiency-related emphysema. This designation highlights the unmet medical need and potential of the drug. Previously, the US FDA granted fast track and orphan drug designation for the same condition. Efdoralprin alfa is in clinical development, with safety and efficacy yet to be evaluated. Sanofi plans to present data at an upcoming medical meeting and engage with global regulatory authorities.