Companies with investigational gene therapies under regulatory review in the EU may be forgiven if they feel less bullish about the commercial prospects for their products today than they did a few days ago. The news that bluebird bio is to wind down commercial initiatives for its gene therapy business in Europe after failing for two years to secure reimbursement for its approved gene therapy Zynteglo (betibeglogene autotemcel) for transfusion-dependent beta-thalassemia (TDT) will have set nerves on edge.
bluebird’s decision to exit the European commercial market highlights the challenges of bringing expensive one-time gene therapies to patients on...
