Bluebird Bio announces EMA acceptance of MAA for LentiGlobin gene therapy

Bluebird Bio announced that the European Medicines Agency accepted the company’s marketing authorization application, or MAA, for its investigational LentiGlobin gene therapy for the treatment of adolescents and adults with transfusion-dependent beta-thalassemia, or TDT, and a non-beta0/beta0 genotype. LentiGlobin was previously granted an accelerated assessment by the Committee for Medicinal Products for Human Use, or CHMP, of the EMA in July 2018, potentially reducing the EMA’s active review time of the MAA from 210 days to 150 days.

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