Bluebird bio Inc. (NASDAQ:BLUE) has announced financial results and business updates for Q3 2020 and also released recent operational progress.
Bluebird bio submits BLA for LentiGlobin™
Nick Leschly, the chief of bluebird, said that although 2020 presents unprecedented challenges, it has continued to advance its innovative gene and cell therapy programs. Looking beyond 2021, the company sees an opportunity as it is on the verge of several EU and US approvals. Leschly said that the company is looking forward to collaborating with the FDA to establish innovative approaches in advancing complex therapies in the near-term. He said that being a pioneer in science is not easy, but bluebird bio is committed to patients it expects to help.
Recently the company confirmed its general agreement with the FDA regarding the clinical data package to support a BLA submission for LentiGlobin™ in treating sickle cell disease. The company will base the BLA submission on data for a section of HGB-206 study Group C Patients that have received treatment before. bluebird bio has announced the signing of a general agreement with the FDA. The agreement is on its commercial manufacturing transition through an analytical comparability approach, including a suspension-based lentiviral vector.
The FDA asked for the use of the drug product manufactured from SCD patient cells. The request includes healthy donors and commercial lentiviral vector to show drug product comparability. Considering the feedback and COVID-19 related changes and impact on contract manufacturing organization, the company is changing its submission timeline to late 2022.
bluebird bio granted PRIME designation for LentiGlobin
On September 23, 2020, the company announced that the EMA granted LentiGlobin Priority Medicines program eligibility for SCD gene therapy. The PRIME initiative will offer enhanced support and interaction with the regulatory agency to optimize development plans and accelerate regulatory evaluation to quickly deliver medicines to patients.
The company is also on track to complete BLA submission in the context of its Break Through Therapy and Fast Track designations for betibeglogen autotemcel in mid-2021.