Benzinga | Oct 21, 2021 12:12PM EDT

bluebird bio To Withdraw Marketing Authorization For SKYSONA From EU And Withdraw Marketing Applicatino For SKYSONA From MHRA

On October 21, 2021, bluebird bio, Inc. announced that as part of the winding down of its operations in Europe, it will withdraw its regulatory marketing authorization for SKYSONA from the European Union, and its marketing application for SKYSONA from the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom (UK). Bluebird bio, Inc. anticipates withdrawing marketing authorizations for ZYNTEGLO from both the EU and the UK by early 2022. The company expects to continue activities for the long-term follow-up of patients previously enrolled within the EU clinical trial programs as planned, but does not intend to initiate any new clinical trials in Europe for the beta-thalassemia, cerebral adrenoleukodystrophy or sickle cell disease programs.