Bluebird Bio Gets FDA OK of Lyfgenia Gene Therapy in Sickle-Cell Disease
09 December 2023 - 4:03AM
Dow Jones News
By Colin Kellaher
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.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
December 08, 2023 11:48 ET (16:48 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.
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