bluebird bio’s Zynteglo (betibeglogene autotemcel), a one-time treatment for transfusion-dependent beta-thalassemia, will roll out with a $2.8mn price tag per dose.
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Over 90 percent of β-thalassemia patients treated with Betibeglogene autotemcel (beti-cel) achieved transfusion independence lasting over a year.
The betibeglogene autotemcel (beti-cel) gene therapy caused paediatric and adult beta thalassaemia patients to achieve transfusion independence lasting over two years.
bluebird bio has chosen to suspend sales of Zynteglo while they investigate whether safety concerns identified with a related investigational gene therapy may apply to the licenced medicine.
The EMA's human medicines committee has adopted a positive opinion for eight medicines, recommending their marketing authorisation.
The EMA CHMP has revealed its suggestion to grant marketing authorisation to seven medicines after its most recent meeting.