MedCity News December 8, 2023
The first gene therapies for sickle cell disease are now approved: Casgevy from Vertex Pharmaceuticals Casgevy and Lyfgenia from Bluebird Bio. Despite the same-day approval, key differences give one of these therapies commercialization advantages over the other.
Gene therapy is now here for patients with sickle cell disease. The FDA on Friday approved treatments from Vertex Pharmaceuticals and Bluebird Bio, each offering a potentially curative treatment for the inherited blood disorder.
Approval for Vertex’s Casgevy came right on the target date for an FDA decision and three weeks after regulators in the United Kingdom made the treatment the first approved CRISPR-based therapy in the world. For Bluebird’s treatment, named Lyfgenia, the approval comes nearly two weeks early. The FDA decisions...
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