FDA extends review times for bluebird bio's BLAs

The US Food and Drug Administration has extended the review period for the biologics licensing applications (BLA) for its lentiviral vector gene therapies – betibeglogene autotemcel (beti-cel) for β-thalassemia and elivaldogene autotemcel (eli-cel) for cerebral adrenoleukodystrophy (CALD), submitted by bluebird bio (Nasdaq: BLUE), whose shares dived more than 11% to $8.27.

The revised PDUFA goal dates for beti-cel and eli-cel are August 19, 2022 and September 16, 2022, delays of three months respectively.

The FDA extended the PDUFA goal dates for beti-cel and eli-cel to allow time to review additional clinical information previously submitted by the company in response to FDA information requests as part of its ongoing reviews. The information was deemed a major amendment. The extension of the FDA review timeline does not relate to new safety events for either beti-cel or eli-cel, the company stressed.