Bluebird Bio Gets FDA OK of Lyfgenia Gene Therapy in Sickle-Cell Disease

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 [e-mail]

(END) Dow Jones Newswires

12-08-23 1148ET