EMA
approval
· 2026-08-27
EMA Authorised: Hemgenix (Etranacogene dezaparvovec) — CSL Behring GmbH
Summary
Authorised gene therapy Hemgenix (etranacogene dezaparvovec) for Hemophilia B with conditional approval by EMA.
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Diseases / indications
Drugs mentioned
Snippet
Status: Authorised. Therapeutic area: Hemophilia B. MAH: CSL Behring GmbH. Decision date: 27/08/2026. Conditional approval. Orphan medicine