Catalyst Wire Dossier Catalyst Wire Dossier
EMA approval · 2026-08-27

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

View source ↗

Summary

Authorised gene therapy Hemgenix (etranacogene dezaparvovec) for Hemophilia B with conditional approval by EMA.

Upgrade for the full analysis, importance score, and drug timeline.

Diseases / indications

Drugs mentioned

  • Hemgenix (etranacogene dezaparvovec)

Snippet

Status: Authorised. Therapeutic area: Hemophilia B. MAH: CSL Behring GmbH. Decision date: 27/08/2026. Conditional approval. Orphan medicine