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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