Posted by Michael Wonder on 23 Apr 2017
Marketing authorisation for Glybera to expire on 25 October 2017
20 April 2017 - Company maintains focus on core programs in haemophilia B, Huntington’s disease and congestive heart failure.
uniQure today announced that it will not pursue the renewal of the Glybera (alipogene tiparvovec) marketing authorisation in Europe when it is scheduled to expire on 25 October 2017.
“The decision to not pursue marketing authorisation 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. “Glybera’s usage has been extremely limited and we do not envision patient demand increasing materially in the years ahead.”
