2020-11-05 04:46:00 BLUE Bluebird Bio
11/05/20 11/0504:46 11/05/2004:46 | Bluebird Bio pushes back sickle cell submission timing to late 2022The company said in last night's earnings release, "Today, bluebird bio announces confirmation of its general agreement with the U.S. Food and Drug Administration that the clinical data package required to support a BLA submission for LentiGlobin for sickle cell disease will be based on data from a portion of patients in the HGB-206 study Group C that have already been treated. bluebird bio is also announcing today that it has reached general agreement with FDA on its path to transition to commercial manufacturing using an analytical comparability strategy, including suspension-based lentiviral vector. These developments meaningfully de-risk the bb1111 program and bring clarity on the path to approval. However, FDA requested the use of drug product manufactured from sickle cell disease patient cells in addition to healthy donors as well as commercial lentiviral vector to demonstrate drug product comparability. Given this feedback, alongside COVID-19 related shifts and contract manufacturing organization COVID-19 impacts, bluebird is adjusting its submission timing to late 2022. The company looks forward to continuing to work with the Agency to find an innovative approach to reviewing the CMC portion of a BLA submission and address the high unmet need in sickle cell disease." |
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