Posted by Michael Wonder on 18 Jan 2022
bluebird provides update on FDA review timelines for betibeglogene autotemcel for beta thalasszemia and elivaldogene autotemcel for cerebral adrenoleukodystrophy
18 January 2022 - FDA PDUFA goal dates for both therapies extended by three months.
bluebird bio today announced that the US FDA has extended the review period for the biologics licensing applications for its lentiviral vector gene therapies – betibeglogene autotemcel for β-thalassemia and elivaldogene autotemcel for cerebral adrenoleukodystrophy.
The revised PDUFA goal dates for beti-cel and eli-cel are 19 August 2022 and 16 September 2022, respectively.
