Bluebird Bio : FDA PDUFA Goal Dates For Lentiviral Vector Gene Therapies Extended By Three Months

The US Food and Drug Administration has extended the review period for the biologics licensing applications or BLA for lentiviral vector gene therapies - betibeglogene autotemcel (beti-cel) for ß-thalassemia and elivaldogene autotemcel (eli-cel) for cerebral adrenoleukodystrophy, bluebird bio Inc. (BLUE) said in a statement on Tuesday.

The company noted that the extension of the FDA review timeline does not relate to new safety events for either beti-cel or eli-cel.

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

The FDA accepted the BLA for eli-cel for patients with cerebral adrenoleukodystrophy under the age of 18 for priority review in December 2021. If approved, beti-cel and eli-cel would be the first lentiviral vector gene therapies for patients with severe genetic diseases in the United States.

In addition, bluebird provided an update on the FDA's partial clinical hold for the lovotibeglogene autotemcel (lovo-cel) gene therapy clinical program for patients under the age of 18 with sickle cell disease.

The company has received written questions from the FDA and is continuing to evaluate what impact, if any, the partial clinical hold may have on its projected the first-quarter 2023 timing for submitting the BLA. The company plans to provide an update with its annual results in February.

In Tuesday pre-market trade, BLUE was trading at $8.62 down $0.11 or 1.26%.

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