EMA accepts filing (MAA) for LentiGlobin gene therapy to treat transfusion-dependent beta-thalassemia.- bluebird bio
bluebird bio, Inc.announced that the European Medicines Agency (EMA) accepted the company�s marketing authorization application (MAA) for its investigational LentiGlobin gene therapy for the treatment of adolescents and adults with transfusion-dependent beta-thalassemia (TDT) and a non-beta0/beta0 genotype.
LentiGlobin was previously granted an accelerated assessment by the Committee for Medicinal Products for Human Use (CHMP) of the EMA in July 2018, potentially reducing the EMA�s active review time of the MAA from 210 days to 150 days. The MAA for LentiGlobin is supported by data from the completed Phase 1/II Northstar (HGB-204) study and the ongoing Phase 1/II HGB-205 study as well as available data from the Phase III Northstar-2 (HGB-207) study and the long-term follow-up study LTF-303.
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