Bluebird gets PDUFA date for lovo-cel; FDA lifts hold on DiaMedica stroke trial
The FDA has accepted the BLA from bluebird bio for its gene therapy lovotibeglogene autotemcel, or lovo-cel, designed to treat patients with sickle cell disease (SCD) who have a history of vaso-occlusive events.
Bluebird announced Wednesday that the agency set the PDUFA date for Dec. 20. The application is based on efficacy results from 36 patients in one study cohort that had 32 months of follow-up examinations, and another group of two patients that had 18 months of follow-up. The submission also has safety data from 50 patients which include six patients that have had over six years of follow-up.
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