It's of­fi­cial: FDA clamps a hold on blue­bird's trou­bled Lenti­Glo­bin pro­gram while EMA con­sid­ers new mea­sures

What start­ed out as a vol­un­tary hold of a crit­i­cal de­vel­op­ment pro­gram at blue­bird bio has gone in­to an of­fi­cial lock­up at the FDA.

The biotech — helmed by Nick Leschly — re­port­ed out in its lat­est quar­ter­ly up­date Tues­day evening that the FDA has or­dered a halt to the clin­i­cal pro­gram for Lenti­Glo­bin for sick­le cell dis­ease, putting the fate of the drug in the hands of reg­u­la­tors. In the mean­time, in Eu­rope, where blue­bird halt­ed com­mer­cial­iza­tion right af­ter the first pa­tient was treat­ed with the gene ther­a­py, the EMA has paused the re­new­al pro­ce­dure for their con­di­tion­al mar­ket­ing OK as the “phar­ma­covig­i­lance risk as­sess­ment com­mit­tee re­views the risk-ben­e­fit as­sess­ment for Zyn­te­glo and de­ter­mines whether any ad­di­tion­al phar­ma­covig­i­lance mea­sures are nec­es­sary.”

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