Our Commitment to the Hemophilia B Community: An Update on HEMGENIX® (etranacogene dezaparvovec-drlb) Availability

Dear Hemophilia B Community,

We are writing to share an important update on the availability of HEMGENIX® (etranacogene dezaparvovec-drlb).

CSL is currently experiencing a temporary global stockout of HEMGENIX® that will result in delays in treatment for some individuals in countries with established commercial access.

We want to be very clear that this situation is not related to the safety or effectiveness of HEMGENIX®. Rather, it reflects the complexity of manufacturing gene therapies, and our commitment to adhering to the highest regulatory and quality standards for the people we serve. We are working with regulatory authorities on strategies to ensure stable ongoing supply for HEMGENIX® while preserving our high-quality standards.

We know that this update may raise questions and that’s completely understandable. What we want you to know is that our highest priority, as always, is ensuring that eligible individuals have the information they need to determine if HEMGENIX® is right for them, and that when they do, HEMGENIX® is available in accordance with the highest standards. We remain fully committed to delivering this innovative, one-time gene therapy to the hemophilia B community and continue to have strong confidence in HEMGENIX®.

​We understand the careful thought and planning that go into every individual decision about gene therapy treatment. We deeply value our long‑standing partnership of trust with the hemophilia B community and will continue to keep you updated to ensure people with hemophilia B and their healthcare providers are informed and supported as they plan their hemophilia care needs.

For further information, please visit our contact page on CSL.com here:
https://www.csl.com/contact.
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Sincerely,
Dr. Deborah Long,
SVP, Medical Affairs