Bluebird's LentiGlobin^TM for sickle cell disease (SCD) gene therapy (bb1111) was granted eligibility to the Priority Medicines (PRIME) program by the European Medicines Agency (EMA). LentiGlobin^TM is an investigational therapy. PRIME provides early and enhanced scientific and regulatory support to medicines that have the potential to significantly address patients’ unmet medical needs. Clinical data from the completed Phase 1/2 HGB-205 study, the ongoing Phase 1/2 HGB-206 study and ongoing long-term safety and efficacy follow-up study LTF-303 supported the PRIME application for LentiGlobin^TM for SCD. The U.S. FDA granted orphan drug designation, fast track designation, regenerative medicine advanced therapy (RMAT) designation and rare pediatric disease designation for LentiGlobin^TM for SCD. LentiGlobin^TM for SCD also received orphan medicinal product designation from the European Commission for the treatment of SCD. For more information, see here.