- ZYNTEGLO has received conditional approval in Europe for those with transfusion-dependent beta-thalassemia. Goal is to expand approval to include pediatric patients and those with ?0/?0 genotype.
- A BLA filing of ZYNTEGLO for the treatment of patients with transfusion-dependent beta-thalassemia and all genotypes in the United States is expected by mid 2021.
- A regulatory submission to the European Medicines Agency of Lenti-D for the treatment of patients with Cerebral Adrenoleukodystrophy is expected by the end of 2020; A U.S. BLA submission is expected mid-2021.
- A BLA submission of Lentiglobin for the treatment of patients with Sickle Cell Disease is expected by the 2nd half of 2021.
For further details see:
bluebird bio Should Be On Your Radar With Multiple Catalysts Expected This Year And 2021