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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