(Reuters) – Advisers to the U.S. Food and Drug Administration on Thursday voted to recommend approval of bluebird bio’s treatment for a rare neurological disorder, bringing it closer to becoming the third gene therapy to be available in the United States.
All 15 committee members voted unanimously that the benefits of elicel for treatment of cerebral adrenoleukodystrophy (CALD) in patients below 18 years who do not have a matched sibling for stem cell transplant, outweigh its risks.
(Reporting by Mrinalika Roy in Bengaluru; Editing by Sriraj Kalluvila)
