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.”

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER