Bluebird Bio Reports Regulatory Strategy For LentiGlobin BB305

(RTTNews) - bluebird bio, Inc. (BLUE), a clinical-stage company, Tuesday said it has met with regulatory authorities in Europe and the U.S. to discuss potential approval pathways for its LentiGlobin BB305 product candidate 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.

bluebird bio is engaged in developing potentially transformative gene therapies for severe genetic and rare diseases and T cell-based immunotherapies.

bluebird has reached general agreement with the U.S. Food and Drug Administration on the design of its planned clinical trials HGB-207 and HGB-208. Based on its discussions with the FDA, bluebird bio believes that data from these trials, together with data from the ongoing beta-thalassemia major clinical studies, could form the basis for a Biologics License Application submission for LentiGlobin BB305.

In Europe, bluebird believes it is possible to seek conditional approval for the treatment of adults and adolescents with beta-thalassemia major on the basis of the totality of clinical data, in particular reduction in transfusion need, from the ongoing Northstar Study and supportive HGB-205 study.