bluebird bio's LentiGlobin accepted into European Medicines Agency's PRIME program

US clinical-stage biotech firm bluebird bio (Nasdaq: BLUE) revealed that the European Medicines Agency has granted access to its Priority Medicines (PRIME) scheme for LentiGlobin drug product in the treatment of patients with transfusion-dependent beta-thalassemia (TDT).

The PRIME initiative provides enhanced support and increased interaction to companies, with the goal of optimizing development plans and speeding regulatory evaluations to potentially bring innovative medicines to patients more quickly. To be accepted for PRIME, a therapy must demonstrate potential to benefit patients with unmet medical need through early clinical data or nonclinical data. Access to the PRIME initiative complements bluebird’s ongoing participation in the EMA’s Adaptive Pathways Pilot program, which also aims to expedite patient access to therapies with the potential to treat serious conditions with unmet need. It uses the existing European Union regulatory framework for medicines, including conditional approval.

“PRIME designation will allow bluebird bio to further improve our communication with European regulators as we continue to refine our evidence generation plan in the context of adaptive biomedical innovation. Overall, we believe this will enable us to accelerate development of LentiGlobin drug product for patients with transfusion-dependent beta thalassemia, a life-shortening disease with significant unmet medical need,” said David Davidson, chief medical officer, bluebird bio.