Three years after the approval by the European Medicines Agency of Zynteglo for adult and pediatric patients with β-thalassemia and no one in Cyprus or Europe in general has benefitted yet.
This week, the US Food and Drug Administration (FDA) has also granted approval for bluebird bio’s Zynteglo marks a watershed moment for the field of gene therapy.
The custom-made, one-dose gene therapy, however, is restricted from European markets due to the inability of the manufacturers to reach financial agreements with European health systems, according to Philenews.
“The FDA’s approval of the treatment is particularly important for thalassemia patients,” head of the Cyprus Anti-Thalassemia Association, Miltos Miltiadou has said.
“The treatment has been approved in Europe since 2019, we are in the second half of 2022 and it has never reached the patients, due to costs, and this is a bleak fact affecting not only Cyprus but Europe in general,” he added.