uniQure not to seek re-approval for Glybera in Europe
Netherlands-based gene therapy company uniQure (Nasdaq: QURE) today announced that it will not pursue the renewal of the Glybera (alipogene tiparvovec) marketing authorization in Europe when it is scheduled to expire on October 25, 2017.
“The decision to not pursue marketing authorization renewal of Glybera in Europe involved a thoughtful and careful evaluation of patient needs and the clinical use of the therapy, and is not related to any risk-benefit concern,” stated Matthew Kapusta, chief executive officer of uniQure, adding: “Glybera’s usage has been extremely limited and we do not envision patient demand increasing materially in the years ahead.”
The European Commission had granted a five-year marketing authorization for Glybera under exceptional circumstances as a treatment for the familial lipoprotein lipase deficiency (LPLD) indication in 2012.
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