bluebird bio Reports the US FDA Acceptance of BLA for lovotibeglogene autotemcel to Treat Sickle Cell Disease in Patients Aged ≥12 Years
Shots:
- The US FDA has accepted the BLA for priority review of lovotibeglogene autotemcel for individuals with SCD aged ≥12yrs. who have a history of vaso-occlusive events (VOEs). The US FDA decision is expected in Dec 2023
- The BLA was based on efficacy results from 36 patients in the (HGB-206) study Group C cohort with a median of 32mos. follow-up and 2 patients in the (HGB-210) study with 18mos. of follow-up. The submission also incl. safety data from 50 patients across the lovo-cel program incl. 6 patients with ≥6yrs. of follow-up
- If lovo-cel is approved, it will be the third ex-vivo gene therapy approved in the US for a rare genetic disease and its second US FDA approval for an inherited hemoglobin disorder
Ref: Businesswire | Image: bluebird bio
Related News:- bluebird bio’s Zynteglo (betibeglogene autotemcel) Receives the US FDA’s Approval for the Treatment of Beta-Thalassemia
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