bluebird bio Announces European Medicines Agency’s Acceptance of Marketing Authorization Application for LentiGlobin™ Gene Therapy for the Treatment of Transfusion-Dependent ß-Thalassemia
bluebird bio, Inc. (BLUE)
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Source: Business Wire
- European Medicines Agency Will Evaluate LentiGlobin Marketing Authorization Application Under Accelerated Assessment - CAMBRIDGE, Mass.--(BUSINESS WIRE)-- bluebird bio, Inc. (Nasdaq: BLUE) announced today 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 ß-thalassemia (TDT) and a non-ß0/ß0 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. “People living with transfusion-dependent ß-thalassemia require frequent blood transfusions that are life-saving but may lead to complications, including organ failure due to iron o
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