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EMA accepts Bluebird Bio's MAA for LentiGlobin gene therapy

  • The European Medicines Agency (EMA) accepts Bluebird Bio's (NASDAQ:BLUE) marketing authorization application (MAA) for its investigational LentiGlobin gene therapy for the treatment of adolescents and adults with transfusion-dependent β-thalassemia (TDT) and a non-β00 genotype.
  • LentiGlobin was previously granted an accelerated assessment by the CHMP of the EMA in July 2018, reducing the EMA’s review time of the MAA from 210 days to 150 days.
  • The MAA is supported by data from the completed Phase 1/2 Northstar (HGB-204) study and the ongoing Phase 1/2 HGB-205 study as well as available data from the Phase 3 Northstar-2 (HGB-207) study and the long-term follow-up study LTF-303.

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