
The U.S. Food and Drug Administration's (FDA) Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) unanimously voted in favour of Bluebird bio’s (NASDAQ:BLUE) elivaldogene autotemcel (eli-cel) for the treatment of early active cerebral adrenoleukodystrophy (CALD) in patients less than 18 years of age.
The advisory committee's recommendation is based on the Biologics License Application (BLA) granted priority review by the FDA with a PDUFA goal date set for September 16, 2022.