The FDA has extended the review period for Bluebird bio Inc's (NASDAQ:BLUE) biologics licensing applications (BLA) for its lentiviral vector gene therapies.
- The agency has pushed the applications for betibeglogene autotemcel (beti-cel) for β-thalassemia and elivaldogene autotemcel (eli-cel) for cerebral adrenoleukodystrophy (CALD).
- The revised PDUFA goal dates for beti-cel and eli-cel are August 19, 2022, and September 16, 2022.
- Related: Bluebird bio's Neurodegenerative Disease Gene Therapy Under Priority FDA Review, Despite Clinical Hold.
- 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.
- The extension of the FDA review timeline does not relate to new safety events for either beti-cel or eli-cel.
- The FDA accepted bluebird's BLA submission for beti-cel for β-thalassemia for priority review in November 2021.
- Bluebird also said that it received written questions from the FDA on partial clinical hold for the lovotibeglogene autotemcel (lovo-cel) gene therapy program for sickle cell disease patients under 18 years.
- The Company continues to evaluate the impact of the partial clinical hold on its projected Q1 2023 timing for submitting the BLA.
- Price Action: BLUE shares are down 2.63% at $8.50 during the premarket session on the last check Tuesday.
