CSL, a global biotechnology company, is experiencing a temporary worldwide stockout of Hemgenix (etranacogene dezaparvovec-drlb), its one-time gene therapy for adults with hemophilia B.
The shortage will delay treatment for some patients in countries where the therapy is commercially available, according to a March 23 news release. CSL said the issue is not related to safety or efficacy but reflects the complexity of manufacturing gene therapies and the company’s adherence to high regulatory and quality standards.
Regulatory discussions are underway to stabilize supply, and no timeline was provided for when availability will resume. CSL said development of Hemgenix for obesity remains unaffected.
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