Posted by Michael Wonder on 06 Oct 2018
bluebird bio announces EMA’s acceptance of marketing authorisation application for lentiGlobin gene therapy for the treatment of transfusion-dependent β-thalassemia
5 October 2018 - EMA will evaluate lentiGlobin marketing authorisation application under accelerated assessment.
bluebird bio announced today that the EMA accepted the company’s marketing authorisation application for its investigational LentiGlobin gene therapy for the treatment of adolescents and adults with transfusion-dependent β-thalassemia and a non-β0/β0 genotype.
The MAA for LentiGlobin is supported by data from the completed Phase 1/2 Northstar (HGB-204) study and the ongoing Phase 1/2 HGB-205 study as well as available data from the Phase 3 Northstar-2 (HGB-207) study and the long-term follow-up study LTF-303.
