Bluebird Bio has delayed the launch of its Zynteglo gene therapy, despite securing conditional approval from the European Medicines Agency, after it demanded a tightening of product specifications and manufacturing processes. The company said on Tuesday that regulatory delays had forced it to delay the start date for the first clinical trial in Europe by two months. It plans to enrol its first patients by the end of this year and begin treatment in early 2020.
Bluebird Bio has delayed the launch of its Zynteglo gene therapy, despite securing conditional approval from the European Medicines Agency, after it demanded a tightening of product specifications and manufacturing processes. Bluebird has priced Zynteglo, which is for people with transfusion-dependent beta-thalassemia, at €1.575m ($1.77m) in Europe, spread over five years. It plans to enrol its first patients by the end of this year and begin treatment in early 2020.