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Friday, December 08, 2023 12:25:30 PM
Bluebird bio has won U.S. Food and Drug Administration approval of its Lyfgenia gene therapy for sickle-cell disease, making it one the first two cell-based gene therapies to win a U.S. green light for the inherited blood disorder.
The FDA on Friday said the approval covers Lyfgenia for the treatment of patients 12 years of age and older with sickle-cell disease and a history of vaso-occlusive events.
The FDA nod, nearly two weeks ahead of the target action date of Dec. 20, comes on the same day the agency cleared the Casgevy gene-therapy from CRISPR Therapeutics and Vertex Pharmaceuticals, marking the first U.S. approval for a drug using the gene-editing technology known as Crispr.
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