Gene Therapy Approval Standards: Available Treatments Influence US FDA’s View On Durability

The US Food and Drug Administration’s view of the importance of durability for a gene therapy depends, in part, on the condition being treated and the existence of other approved therapies.

Speaking at the virtual Cell & Gene Meeting on the Mesa on 14 October, Center for Biologics Evaluation and Research director Peter Marks said the agency assesses the importance of durability of effect differently for a gene therapy that treats a disease that has no