European regulator grants accelerated assessment to bluebird's LentiGlobin
East Coast, USA-based biotech firm bluebird bio (Nasdaq: BLUE) has been granted an accelerated assessment by the European regulator for its LentiGlobin gene therapy.
The firm is investigating LentiGlobin as a treatment for certain patients with transfusion-dependent β-thalassemia (TDT), an inherited blood disorder which can lead to serious complications and organ damage.
The expedited status could knock a quarter off the time the European Medicines Agency takes to review a regulatory filing in this indication, down to around five months.
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