Lessons Learned from the Clinical Development and Market Authorization of Glybera
Laura Bryant(University of Pennsylvania), Devin M. Christopher(Gene Therapy Laboratory), April R. Giles(Gene Therapy Laboratory), Christian Hinderer(Gene Therapy Laboratory), Jesse L. Rodriguez(Gene Therapy Laboratory), Jenessa B. Smith(Gene Therapy Laboratory), Elizabeth A. Traxler(Gene Therapy Laboratory), Josh Tycko(Gene Therapy Laboratory), Adam Wojno(Gene Therapy Laboratory), James M. Wilson(Gene Therapy Laboratory)
Cited by 185Open Access
Abstract
Bryant and colleagues follow the development of Glybera (alipogene tiparvovec), the first gene therapy product approved in the European Union, from early preclinical studies through the approval process. They review key data from human and animal studies with an emphasis on issues that will be critical to other gene therapy products. The article concludes with an analysis of the complex review process that eventually led to Glybera's approval.
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