With LentiGlobin cleared by FDA, bluebird lifts EU marketing hold on gene therapy using the same delivery mechanism
With the FDA finally off its back on its LentiGlobin sickle cell program, bluebird bio is heading into its big split-up with a mostly clear path for its rare disease unit. The one remaining hang-up was the status of the beta thalassemia gene therapy Zynteglo in the EU, but bluebird’s flight path now seems clear there, too.
Zynteglo will now be back on the market in the EU after an EMA safety committee determined the treatment’s risk-benefit profile skewed enough in its favor to stay on the market, the drugmaker said Friday.
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