FDA Approves Gene Therapy for Inherited Blood Disorder

Published on January 17, 2024

The U.S. Food and Drug Administration (FDA) has approved a gene therapy to treat an inherited blood disorder, even as the agency earlier expressed concerns about the technology leading to “unintended” gene edits. “Casgevy, a cell-based gene therapy,” was approved “for the treatment of patients 12 years of age and older with transfusion-dependent beta-thalassemia, an inherited disorder characterized by life-long anemia requiring frequent blood transfusions,” the FDA said in a Jan. 16 announcement. A patient’s blood stem cells are extracted, modified, and transplanted back into the individual’s bone marrow where they attach and multiply. Modified cells then boost the production of fetal hemoglobin, which facilitates oxygen delivery and decreases the severity of anemia....

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