Bluebird bio, Inc. announced that it has met with regulatory authorities in EU and USA to discuss potential approval pathways for its LentiGlobin BB305 for the treatment of beta-thalassemia major.
These discussions have resulted in general agreement from both agencies regarding bluebird bio's development plans, which could potentially result in accelerated approvals. The EMA Adaptive Pathways pilot program will allow to pursue conditional approval for the treatment of beta-thalassemia major on the basis of clinical data from the ongoing HGB-204 and HGB-205 studies. This feedback brings us closer to achieving our vision of delivering one-time, potentially transformative gene therapy to patients.
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