EMA Authorised: Hemgenix (Etranacogene dezaparvovec) — CSL Behring GmbH

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Summary

The EMA authorised Hemgenix (etranacogene dezaparvovec) from CSL Behring for hemophilia B. The approval is conditional and carries orphan medicine status.

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Diseases / indications

• Hemophilia

Drugs mentioned

• Hemgenix (etranacogene dezaparvovec)

Snippet

Status: Authorised. Therapeutic area: Hemophilia B. MAH: CSL Behring GmbH. Decision date: 29/01/2026. Conditional approval. Orphan medicine