Bluebird Bio: European Medicines Agency To Review Eli-cel MAA Under Accelerated Assessment

(RTTNews) - bluebird bio, Inc. (BLUE) announced the European Medicines Agency accepted its marketing authorization application for investigational elivaldogene autotemcel gene therapy for the treatment of patients with cerebral adrenoleukodystrophy. In July, the CHMP of the EMA granted an accelerated assessment to eli-cel, potentially reducing the active review time of the MAA from 210 days to 150 days.

Eli-cel is a one-time investigational gene therapy designed to add functional copies of the ABCD1 gene into a patient's own hematopoietic stem cells that have been transduced ex vivo with the Lenti-D lentiviral vector.

The company noted that it is currently on track to submit the Biologics License Application in the U.S. in mid-2021.