Drugs / CSL222
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT07080905 | Jul 2025 → Oct 2033 expected | hemophilia B | CSL Behring | Recruiting | No outcome recorded |
| Phase 3 | NCT06003387 | Jan 2024 → Oct 2028 expected | hemophilia B | CSL Behring | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2023-02-20 | CSL Behring | Regulatory First Gene Therapy for Hemophilia B, CSL's HEMGENIX®, Approved by the European Commission csl.com ↗
Global biotechnology leader CSL (ASX: CSL) today announced that the European Commission has granted conditional marketing authorization (CMA) for HEMGENIX ® (etranacogene dezaparvovec), the first and only one-time gene therapy for the treatment of severe and moderately severe hemophilia B (congenital Factor IX deficiency) in adults without a history of Factor IX inhibitors. |
| 2022-12-16 | CSL Behring | Regulatory CSL Receives Positive CHMP Opinion for Etranacogene Dezaparvovec – Gene Therapy for Adults with Hemophilia B csl.com ↗
CSL (ASX: CSL) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending conditional marketing authorization (CMA) of etranacogene dezaparvovec. |
| 2022-11-02 | CSL Behring | Regulatory Next-Generation mRNA, Gene Therapy, Plasma Products, Monoclonal Antibodies, and Recent Acquisitions and Collaborations Highlight CSL R&D Day 2022 csl.com ↗
Etranacogene dezaparvovec (also known as CSL222), an investigational gene therapy for the treatment of adults with haemophilia B has been accepted for priority review by the United States (US) Food and Drug Administration (FDA) and standard review by the European Medicines Agency (EMA). |
| 2022-05-24 | UniQure Biopharma B.V. | Regulatory uniQure Announces FDA Acceptance of Biologics License Application for Etranacogene Dezaparvovec under Priority Review gcs-web.com ↗ |
| 2022-05-24 | CSL Behring | Regulatory FDA Accepts CSL Behring's Biologics License Application for Etranacogene Dezaparvovec for Priority Review csl.com ↗
FDA's acceptance of the etranacogene dezaparvovec BLA for priority review is another pivotal milestone in CSL Behring's commitment to deliver innovative treatment options that address unmet needs for people living with rare diseases |
| 2022-03-28 | CSL Behring | Regulatory European Medicines Agency Commences Review of Novel Gene Therapy Candidate Etranacogene Dezaparvovec for People with Hemophilia B csl.com ↗
CSL Behring today announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for etranacogene dezaparvovec (EtranaDez) under its accelerated assessment procedure. |
| 2022-02-04 | CSL Behring | Results Final Analysis of Pivotal HOPE-B Study Demonstrates Durable and Sustained Therapeutic Effect of Etranacogene Dezaparvovec Gene Therapy in Hemophilia B - Data Presented at EAHAD 2022 csl.com ↗
Global biotherapeutics leader CSL Behring today announced positive long-term results from the Phase 3 HOPE-B clinical trial evaluating etranacogene dezaparvovec (EtranaDez), an investigational adeno-associated virus five (AAV5)-based gene therapy for people living with hemophilia B, a life-threatening bleeding disorder. |
All press releases naming this drug 7 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | CSL222 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06003387 ↗ |
| Known as | AAV5-hFIXco-Padua | “CSL222 (AAV5-hFIXco-Padua)” NCT06003387 ↗ |
| Modality | Gene therapy (AAV / viral vector) | “CSL222 (Etranacogene Dezaparvovec) Gene Therapy” NCT06003387 ↗ |
| Route | Intravenous | “Administered as a single IV infusion.” NCT06003387 ↗ |