CSL Behring Provides Update on HEMGENIX Availability

CSL Behring today announced an important update on the availability of HEMGENIX® (etranacogene dezaparvovec-drlb) in the United States.

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. 

CSL Behring has provided a letter with details of the product update. Read the full letter here.