Bluebird Bio: FDA Extends Reviews of Beti-Cel, Eli-Cel

By Colin Kellaher

Bluebird bio Inc. on Tuesday said the U.S. Food and Drug Administration has extended by three months its review of the company's applications seeking approval of a pair of gene therapies.

The Cambridge, Mass., biotechnology company said the extensions give the FDA more time to study additional clinical information bluebird submitted in response to requests by the agency as part of its reviews.

Bluebird said the revised target action date for betibeglogene autotemcel, or beti-cel, which the FDA is reviewing for patients with the inherited blood disorder beta thalassemia, is now Aug. 19, while the new target date for and elivaldogene autotemcel, or eli-cel, for cerebral adrenoleukodystrophy, is Sept 16.

Bluebird noted that the extended review isn't related to new safety events for either drug, and that it doesn't expect the new target action dates to affect the priority-review status of either application or the potential for the company to receive priority-review vouchers upon approval of either drug in 2022.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

January 18, 2022 07:52 ET (12:52 GMT)

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