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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