25 March 2019 - A third party press release was issued today stating that the EMA issued an approval for the conditional marketing authorisation application for LentiGlobin, bluebird bio’s investigational gene therapy for the treatment of transfusion dependent β-thalassemia.
LentiGlobin for transfusion dependent β-thalassemia (TDT) is scheduled to be reviewed as part of the CHMP meeting from March 25 – 28, however no opinion has been issued by the CHMP.
If the CHMP’s opinion is issued it would then be reviewed by the European Commission, which has the authority to grant approval for the use of LentiGlobin in the EU.