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Benzinga
Benzinga
Technology
Vandana Singh

FDA Pushes Review Period For Bluebird bio's Neurodegenerative Disease, Thalassemia Gene Therapies

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.
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