CSL Behring’s Hemgenix granted first ever direct access in France for haemophilia B gene therapy

CSL Behring

13 December 2023 - CSL Behring has been granted Direct Access for Hemgenix (etranacogene dezaparvovec) by the French Ministry of Health, marking the first treatment to be authorised by this innovative process in France.

Hemgenix is the first and only one time gene therapy for the treatment of severe and moderately severe haemophilia B (congenital Factor IX deficiency) in adult patients without a history of factor IX inhibitors. Through Direct Access, appropriate people living with haemophilia B will now be able to access Hemgenix.

Read CSL Behring press release 

Michael Wonder

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Michael Wonder

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Regulation , France , Gene therapy